Austrianova and San Raffaele University & Research Hospital initiate a Joint Development Programme to prevent the progression of multiple myeloma

SINGAPORE, 19-May-2023 — /EPR BIOTECH NEWS/ — Multiple myeloma is an incurable neoplasia of plasma cells causing anaemia, hypercalcemia, renal insufficiency, and bone lesions. This is due to malignant plasma cells accumulating in bone marrow — the soft, spongy tissue at the centre of bones — crowding out the normal plasma cells that help fight infection. Multiple myeloma usually presents at an potentially curable, asymptomatic stage (also known as smouldering/indolent). However, around 50% of patients go on to develop symptomatic disease and need treatment within 5 years of initial diagnosis. The gut microbiota modulates progression from smouldering disease to full-blown multiple myeloma, and several clinical and preclinical studies have also highlighted the role of the gut microbiota in patients’ response to current therapies (Brevi et al 2022). In 2022, there were 34,470 new cases of multiple myeloma and 12,640 deaths in the USA alone.

Austrianova and San Raffaele University & Research Hospital, Milan, Italy have just announced the initiation of a Joint Development Programme with the aim of creating a treatment to prevent the progression of multiple myeloma to full blown disease by manipulating the microbiome.

The group of Dr. Matteo Bellone, leader of Cellular immunology Unit at San Raffaele University & Research Hospital, has shown that Prevotella melaninogenica, a commensal bacterium of the human gastrointestinal microbiota, can protect against the progression of relatively benign asymptomatic multiple myeloma to the aggressive form of the disease. Delivery of Prevotella melaninogenica in preclinical animal models prevents this progression (Calcinotto et al., 2018) but large doses of the bacteria are needed since they must survive passage through the strongly acidic environment of the stomach. Austrianova, an Asian biotech company operating in Singapore and Thailand, has developed its unique, patented Bac-in-a-Box® technology specifically to efficiently protect bacteria from stomach acid as well as to allow storage at room temperature without appreciable loss of viability (Gunzburg et al., 2020).

This collaboration builds on San Raffaele Hospital’s dedication to technology transfer, the process of partnering with industry to successfully translate research results into medical benefits.

Dr. Bellone said: “Most patients affected by smouldering myeloma live in anxiety because they know the disease may easily evolve into an untreatable phase, but they are offered no preventive cure. It is unexpected that a treatment as simple as taking a probiotic positively impacts disease progression in animal models and might indeed help these patients. We are eager to test Austrianova technology in our models. This will be the first step to the clinic.”

Prof. Walter H. Gunzburg, Chairman of Austrianova, stated: “The Austrianova team is excited to be working with our colleagues at San Raffaele hospital to progress this strategy for hampering the full progression of this devastating blood cancer. Our Bac-in-a-Box® technology is ideally suited to efficiently store and deliver bacteria to the gastric tract and we look forward to applying it to the delivery of Prevotella melaninogenica to hopefully prevent progression of multiple myeloma in patients.”

References

Brevi A, Cogrossi LL, Lorenzoni M, Mattorre B, Bellone M. The Insider: Impact of the Gut Microbiota on Cancer Immunity and Response to Therapies in Multiple Myeloma. Front Immunol 2022;13:845422.

Calcinotto A, Brevi A, Chesi M, Ferrarese R, Garcia Perez L, Grioni M, et al. Microbiota-driven interleukin-17-producing cells and eosinophils synergize to accelerate multiple myeloma progression. Nat Commun 2018;9:4832.

Walter H GunzburgMyo Myint AungPauline ToaShirelle NgEliot ReadWee Jin TanEva Maria BrandtnerJohn DangerfieldBrian Salmons. Efficient protection of microorganisms for delivery to the intestinal tract by cellulose sulphate encapsulation. Microbial Cell Fact. 2020 Nov 26;19:216. doi: 10.1186/s12934-020-01465-3.

About Austrianova

Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).

About San Raffaele University and Research Hospital

Ospedale San Raffaele is a clinical-research-university hospital established in 1971 to provide international-level specialised care for the most complex and difficult health conditions. OSR is part of Gruppo San Donato, the leading hospital group in Italy. The hospital is a multi-specialty center with over 60 clinical specialties; it is accredited by the Italian National Health System to provide care to both public and private, national and international patients. Research at OSR focuses on integrating basic, translational and clinical activities to provide the most advanced care to our patients. The institute is recognized as a global authority in molecular medicine and gene therapy and is at the forefront of research in many other fields. Ospedale San Raffaele is a first-class institute which treats many diseases and stands out for the deep interaction between clinical and scientific area. This makes the transfer of scientific results from the laboratories to the patient’s bed easier. Its mission is to improve knowledge of diseases, identify new therapies and encourage young scientists and doctor to grow professionally.

XSpline Cloud, first-in-class cloud platform for personalized cardiac resynchronization therapy, evaluated in International Clinical Trial

BOLZANO/ BOZEN, Italy, 19-Mar-2023 — /EPR BIOTECH NEWS/ — XSpline SPA, a start-up company incorporated in Bolzano (Italy) and the Ordensklinikum Linz Elisabethinen Hospital in Linz (Austria) today announced the first patient enrolled in a clinical study (ClinicalTrials.govID: NCT05327062) for the cardiac resynchronization therapy (CRT) guided by non-invasive electrical and venous anatomy assessment.  The international multicenter prospective study will include 150 patients from 16 centers in the U.S. and Europe.

XSpline Cloud provides a cloud-based non-invasive cardiac panoramic mapping technology to select individual CRT treatment strategy and predict outcomes.

Fast and fully automatic Artificial Intelligence based epi- and endocardial segmentation of cardiac structures, including coronary sinus veins, provides clear understanding of individual patient’s anatomy. The electrical assessment is based on a 3D panoramic electro-anatomical map based on 12 -lead ECG only, without requiring multichannel ECG recording or any kind of body surface potential mapping. XSpline Cloud is the first system in the world with AI based identification of the correct target zone for LV lead implantation.

The cloud-platform guarantees full operability with existing clinical standards and data formats; it supports IHE profiles, HL7 FIHR, DICOM, and a broad range of ECG formats. The platform also provides embedded medical grade visualization tools, such as an integrated multimodality DICOM viewer, an ECG viewer with measurement capabilities, a high-performance 3D viewer for segmented cardiac structures and electro- anatomical maps as well as an interactive navigator for LV lead placement.

Dr. Georgios Kollias, M.D., is the principal investigator for the clinical trial in Austria and performed the first procedure on a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%.

“The XSpline Cloud software provides a unique approach to selecting an individualized CRT treatment strategy. It is a comprehensive tool for successful CRT implantation that can also predict outcomes, making the implantation procedure faster, easier, and safer for the patient. We are very pleased to start using this tool in our clinic”, said Dr. Kollias.

“XSpline SPA is supported by an international R&D team of skilled clinicians, mathematicians, and biomedical engineers with the shared goal of improving patient care. We think that the real-time visualization of each patient’s individual anatomy, the precise non-invasive electro-anatomical endo- and epicardial activation map and the interactive navigator will help to increase CRT responders”, said Mr. Werner Rainer, CEO of the company.

XSpline Cloud is an investigational device and not yet approved for commercial use.

SOURCE: EuropaWire

Austrianova Secures Significant Investment from Real Tech Fund

 

SINGAPORE, 2021-Jul-7 — /EPR BIOTECH NEWS/ — Austrianova (the SG Austria group, Austrianova Singapore and Austrianova Thailand) is pleased and honoured to announce that, after extensive due diligence, Real Tech Fund (managed by Real Tech Holdings, Japan) has invested an undisclosed seven figure amount in Austrianova via its Real Tech Global Fund 1 to accelerate Austrianova’s growth. Real Tech Fund is a venture capital firm that invests specifically in innovative deep-technology startups mainly in Japan and Southeast Asia. Austrianova was assisted in this transaction by Square Associates. The financing from Real Tech coincides with, as well as bolsters, the Company’s next stage of growth in production capacity in order to satisfy the strong demand witnessed across the wide variety of applications that its unique protective cell encapsulation technology addresses. It also enhances and facilitates Austrianova’s entry into the Japanese market and specifically partnerships with clients benefiting from Austrianova’s Cell-ina-Box® and Bac-in-a-Box® technologies.

“We are pleased that Real Tech has decided to invest in Austrianova as well as that they are convinced of the value of the Cell-in-a-Box® and Bac-in-a-Box® technologies for solving serious problems faced by the planet and by humanity” stated Walter H Gunzburg, Chairman of Austrianova. “Real Tech already has proven to be a valued partner as well as a significant investor in Austrianova and we look forward to working closely together in the future” added Brian Salmons, CEO of Austrianova.

 

About Austrianova
Austrianova (the SG Austria Group), is a biotech company with a global footprint and operations in Singapore and Thailand. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The
technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications as well as rebalancing the microbiome due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, enzymes, recombinant proteins, exosomes etc).

About Real Tech
Real Tech Holdings / Real Tech Fund is a joint venture fund between euglena Co.,Ltd and Leave a Nest Co., Ltd.  It supports change makers who give their heart and soul to solve societal and environmental challenges. Real Tech Holding’s manages Real Tech Fund, Japan’s leading deep-tech focused venture capital fund.
For more information: https://www.realtech.holdings

Forward-Looking Statements
This release includes forward-looking statements regarding Austrianova (the Company) and its respective businesses. Such statements are based on the current expectations of the management of each entity. The forward-looking events and circumstances discussed in this release, including completion of the public offering, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks affecting the Company, economic factors and the equity markets generally. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Austrianova undertakes no obligation to publicly update or revise any forwardlooking statement, whether as a result of new information, future events, or otherwise. This is not an offer or solicitation to buy or sell any securities.

Financial Information Contact: pierre.faddoul@square-associates.com
Company and Technology Contact: salmons@sgaustria.com
For more information: http://www.austrianova.com

SOURCE Austrianova

Clinical trial started to verify whether the use of a nasals spray preparation containing azelastine can help fight COVID-19

SAARBRÜCKEN / VIENNA, 17-Feb-2021 — /EPR BIOTECH NEWS/ — In the fight against the SARS-CoV-2 virus, a large number of pharmaceutical companies are looking for new approaches to combat the pandemic. In addition to vaccines, intensive research and development efforts around the world are focusing on identifying new anti-COVID therapeutics that includes re-evaluation of existing product portfolios with a view to re-purpose drugs that have antiviral properties.

With this goal in mind, URSAPHARM Arzneimittel GmbH, based in Saarbrücken, and the Vienna-based biotech company CEBINA GmbH (Central European Biotech Incubator and Accelerator) are collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic. Azelastine has been successfully used for many years in anti-allergic therapy.

Starting with a novel computational drug repurposing prediction method, developed and performed by Prof Dr Robert Konrat (University of Vienna), CEBINA selected already approved active substances for experimental testing in collaboration with Prof Dr. Ferenc Jakab (Virology National Laboratory, Szentágothai-Research-Center, University of Pécs, Hungary). This collaborative effort led to the identification of azelastine as a potent antiviral compound effective against SARS-CoV-2, a finding confirmed by now by several independent research groups. The potent anti-SARS-CoV-2 activity of azelastine was demonstrated in a reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available nasal sprays [1].

A clinical trial has started on February 16th 2021 to verify whether the use of a nasal spray preparation containing azelastine can achieve a reduction in viral load in the the nasal cavity. The aim of the study is to show whether the anti-allergic medication Pollival® Nasal Spray, or a diluted version, can achieve a reduction in the viral load, therefore reducing transmission and positively influencing the course of the disease.

If positive results of the running clinical studies are demonstrated, URSAPHARM Arzneimittel GmbH and CEBINA GmbH believe this will be an important new approach to control viral spread and contain the current pandemic.

SOURCE: EuropaWire

Complete protection of probiotics from destruction by stomach acid using Bac-in-a-Box technology

SINGAPORE, 2020-Nov-30 — /EPR BIOTECH NEWS/ — Austrianova announced today that a key publication on the ability of its patented technology, Bac-in-a-Box®, to completely protect probiotics from acidic conditions found in the stomach has been published in the well respected journal “Microbial Cell Factories”
https://rdcu.be/cbn0O.

Stomach acid is nature’s way of ensuring that any microbes in food are killed before they reach the intestines. In the same way, stomach acid is also a formidable barrier to the delivery of beneficial bacteria and yeast such as probiotics to the gut, necessitating the current million times “overdosing” of such bacteria. Even then, only a tiny fraction of probiotics survive transit through the stomach. The currently available protections and coatings are only partially effective and still result in the loss of millions of bacteria and the search is still on for novel protective agents and technologies to improve on this.

The stringently reviewed data presented in Austrianova’s Microbial Cell Factories paper show that Bac-in-a-Box® protects living micro-organisms (including probiotics) from stomach acid and bile, enabling them to reach the intestine in a viable state, thereby resulting in a greater beneficial effect. It also allows the use of ten thousand times lower doses, contributing to cost effectivity. Thus, Bac-in-a-Box® is ideal for enhanced and effective delivery of probiotics as well as of oral living vaccines, and it can even be used for microbial fecal transplantation (FMT or bacteriotherapy) where it provides a more patient friendly and acceptable means of delivering stool microbiota.

Brian Salmons, CEO of Austrianova, said “We are pleased that our publication on acid protection of encapsulated microbes has been published in Microbial Cell Factories, an open access, peer-reviewed journal, published by Springer Nature, that is the world leading, primary research journal fully focusing on Applied Microbiology.”

Elaborating on the significance of the paper, Prof. Walter H. Gunzburg said “The gut microbiota in humans and animals plays a key role in health by aiding digestion as well as regulating the immune system and protecting against disease causing pathogens. In recent years, changes or imbalances in the gut microbiota (dysbiosis) have been linked to many diseases as disparate as irritable bowel syndrome, dementia and diabetes, and evidence is
growing that restoring the balance of the microbiota by delivery of probiotic microorganisms can improve health. Orally delivered micro-organisms must survive transit through lethal, highly acid conditions in the stomach and current methods to protect probiotic microorganisms are still not effective enough. This paper reports that Austrianova’s proprietary encapsulation technology, Bac-in-a-Box®, protects members of the microbiota from stomach acid and bile. A number of probiotic strains were shown to survive low pH in vitro for at least 4 hours without appreciable loss in viability as compared to their respective non-encapsulated counterparts. Moreover, animal studies reveals that once the capsules arrive in the intestine (the site where they are needed to have beneficial effects), the probiotics are released and colonize the intestinal tract. Thus, Bac-in-a-Box® protects bacteria and yeasts from viability losses due to stomach acid, allowing the use of lower oral doses of probiotics and microbiota, whilst ensuring good intestinal delivery and release.”

About Austrianova
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).

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Combined Shigella and ETEC vaccine candidate enters Phase 1 clinical study with radically innovative approach

VIENNA, 24-Sep-2020 — /EPR BIOTECH NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.

Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.

“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.

“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.

Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.

SOURCE: EuropaWire

Cells for Cells and Austrianova announce publication on novel method to produce stem cell exosomes

SINGAPORE, 2020-May-22 — /EPR BIOTECH NEWS/ — Austrianova and Cells for Cells have just jointly published a ground breaking, peer reviewed, scientific publication on a novel, cost and time-saving method to generate extra-cellular vesicles (EVs) from encapsulated Mesenchymal Stem Cells (MSCs). These EVs are known to mediate many of the therapeutic effects of stem cells. The authors show that Austrianova’s proprietary Cell-in-a-Box encapsulation technology can be used to produce and deliver EVs from encapsulated MSC’s, as demonstrated using Cells for Cells proprietary MSCs.  The publication, which was co-authored with their academic partners, the University of the Andes, Chile and the University of Veterinary Medicine Vienna, Austria appeared in prestigious international journal “Frontiers in Pharmacology” (Front. Pharmacol., 21 May 2020 | https://doi.org/10.3389/fphar.2020.00679   https://www.frontiersin.org/articles/10.3389/fphar.2020.00679/full)

Currently, EVs have to be purified from cell culture conditioned media using tedious, costly and time-consuming protocols that are difficult to perform under Good Manufacturing Practices (GMP) conditions. The Cell-in-a-BoxÒ encapsulation technology allows efficient enrichment of EVs at high concentration since they are released from the encapsulated cells via the semipermeable pores, which selectively enable the release of small particles but not of the MSCs. Moreover, Cell-in-a-BoxÒ provides 3D culture conditions for the MSCs. The technology can be used in cell culture allowing GMP production. Alternatively, the encapsulated cells can be implanted into patients as a retrievable delivery device that shields the cells from clearance, whilst they continuously produce EVs, growth factors, hormones and other small therapeutically relevant molecules. Moreover, the EVs produced after encapsulation can themselves be used as drug-loaded delivery vehicles. This technology will be invaluable for the treatment of regenerative diseases and Inflammatory disease.

Maroun Khoury, CSO of Cells for Cells said “this is a multifaceted project bringing together different expertise  to support the burgeoning field of EV-based therapies. It will be interesting to test in the near future, the continuous  release of EVs in a in vivo context. At a personal level, it was  a great way to stay connected with colleagues that I met while living in Singapore ”.

Brian Salmons, CEO of Austrianova said “we are pleased that these results representing the culmination of a long term project with our colleagues at Cells for Cells are finally publicly available. The encapsulation of stem cells as a means to produce exosomes using our Cell-in-a-BoxÒ is an exciting technological breakthrough that is applicable for all stem cell types.”

About Austrianova

Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).

About Cells for Cells

Cells for Cells is a Chilean biotechnological company dedicated to the research, development and commercialization of innovative cellular therapies, complying with high standards of scientific, technological and international quality, through manufacturing processes certified under ISO 9001: 2015. Each therapy is produced in our labs with GMP standards, being the first biotech company, with such high-quality standards at Latin American level. Our therapies are applied by duly certified specialists.

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CoapTech and Fidmi Medical to Collaborate on Groundbreaking G-Tube Systems

Baltimore, MD, 2019-Sep-18 — /EPR BIOTECH NEWS/ — CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes). The collaboration between CoapTech and Fidmi will focus on integrating the company’s two technologies and expanding their collective market opportunities.

Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 months.

CoapTech’s PUMA-G System allows initial gastrostomy tube placement by non-surgeons/ gastroenterologists, outside of the endoscopy suite, using point-of-care ultrasound at the patient bedside. This novel approach can be performed in the ICU, emergency room, and eventually outside of the hospital setting, substantially reducing costs for tube placement.

Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged, clogged, or infected, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard PEG tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ g-tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.

Fidmi Medical Chairman, Lloyd Fishman, commented, “We are excited to collaborate with CoapTech in development and marketing. Both companies have developed cutting-edge technologies that will improve patient care and contribute to the ease, efficiency and confidence of clinicians’ work in the gastrostomy field.”

Dr. Steven Tropello, CoapTech’s founder and CMO said, “In combination these systems will be compatible with Push or Pull methods, be implantable in a wide variety of clinical settings, and require minimal readmission to the hospital and fewer visits to the ER. The synergy will reduce both front and back-end costs for hospitals and payers, and make care safer and more patient-centered.”

Via EPR Network
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Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

RENNES, FRANCE, 2019-Apr-08 — /EPR BIOTECH NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors

Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.

Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.

Via EPR Network
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Global leader in flexible containment solutions ILC Dover expands its Irish production footprint by opening a location in Blarney, County Cork, Ireland

FREDERICA, DE, USA, 01-Nov-2018 — /EPR BIOTECH NEWS/ — ILC Dover, a global leader in flexible containment solutions for the pharmaceutical and biopharmaceutical industry is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland.

The building will be operational in the first quarter of 2019 and outfitted with 4,000 square feet of

ISO 7 clean room capacity and 6,500 square feet of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines. When at full production, the company expects to hire 60-70 new ILC Dover employees. The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.

ILC Dover President and CEO Fran DiNuzzo expressed enthusiasm about the new launch: “The expansion of our production capabilities in Ireland will allow us to better serve our global customer base and strengthen our position as the leading single-use powder handling solutions provider to the global pharmaceutical and biopharmaceutical marketplace.”

In addition to production space, the new facility will contain state-of-the-art offices, meeting rooms and a product demonstration area for client visits. Curtis Gingles, Vice President and General Manager of the company’s Pharmaceutical Division, added, “Clients of ILC Dover will be happy to see that we’re focused on providing additional capacity located in the region with expanded technical resources. The market for our products is experiencing incredible growth and this expansion will ensure we can keep up with the growing demand for the high-quality products used in manufacturing lifesaving therapies.”

SOURCE: EuropaWire

Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence

LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR BIOTECH NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.

Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence

In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.

Urinary Incontinence Treatment Options

Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.

Unique Fotona SMOOTH® Technology for Maximum Safety

Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.

Evidence-Based Laser Medicine

Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.

In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.

Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.

The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.

SOURCE: EuropaWire

FINALLY, A REAL INNOVATION IN DENTAL CARE – THE ONLY DUAL MODE LIGHT THERAPY ELECTRIC TOOTHBRUSH LAUNCHES ON KICKSTARTER

Los Angeles, California, 2018-Mar-26 — /EPR BIOTECH NEWS/ — Bristl combines proven science of light therapy with sonic vibration to improve oral care. The company also offers a subscription service to replace brush heads, so having the best oral health is also convenient.

Available on Kickstarter on Monday, March 26th at 9am (PST)

The combination of Bristl’s features, convenience, and style make for true market disruption:

Gum Health
Visible Red light (620–750 nm in wavelength) has been clinically proven to heal gum tissue and prevent inflammation. The same technology is often used in skincare; Bristl is bringing it to the everyday tooth brushing routine.

Kill Bacteria
Visible blue light (450–495 nm in wavelength) has been clinically proven to kill and prevent oral bacteria that causes gingivitis and other gum disease. This safe and natural blue light is proven to be effective, and Bristl is proud to bring it to market.

Get Rid of Plaque
Bristl has three sonic vibration modes: regular, gentle, and off. Sonic vibration is recommended by dentists as it has the highest cleaning ability without damaging gums. The brush head is also particularly designed to reach in crack and crevices while letting light pass through the bristles.

A Few Stats
According to a study published in the Journal of Periodontology and Implant Science (Vol. 44: pp. 280-287), Bristl’s technology (even with only red light) was effective in achieving the following:

  • 86% reduction in bacteria that causes destruction of tooth supporting tissue
  • 117% improvement in PPD (Periodontal Pocket Depth) which indicates gum health
  • 80% improvement in CAL (Clinical Attachment Level) which is another metric for gum health

Why Us?
The Bristl Science team consists of a group of innovators and scientists looking to use advanced technology to improve everyday lives. While we of course wish to build a successful business, we are doing so responsibly; Bristl has committed to donating a percentage of every sale to America’s Toothfairy to provide underserved children with dental care. Whether a customer or an underserved child, we’re on a mission to maximize oral health everywhere.

This is just the beginning. The Bristl Science team will work tirelessly to innovate and build products that improve lives, maximize health, and promote good. The Bristl light therapy toothbrush is just the first step toward a healthier future.

Clinical backing, photos, founders quotes, and more information can be found in our Media Kit:
http://bit.ly/2HtKTJ8

Campaign Preview: https://www.kickstarter.com/projects/574806194/565862801?ref=450743&token=dbd4feaa

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International Symposium on the Accessibility to High-Value Medicine, December 5-6, 2017 in London

LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.

The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.

“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,” says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.

“There is an incredible challenge for the sustainability of health systems across the world”, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,” he adds.

Yann Le Cam, CEO of EURORDIS-Rare Diseases Europe, an alliance of over 700 rare disease patient organisations, commented, “The majority of people living with a rare disease have delayed or no access to the medicine they need. Only through a collective engagement between all stakeholders involved, including industry, competent authorities, health ministries, academics and regulators, can we break the access deadlock.” Le Cam will be presenting a new four-pillar approach to improve access to rare disease therapies in Europe.

The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.

Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org

SOURCE: EuropaWire

S-ACQUISITION CORP COMMENCES TENDER OFFER OF ASTRA LOGICS, INC.

New York, 2017-May-02 — /EPR BIOTECH NEWS/ — S-Acquisition Corporation is today commencing its tender offer for all 10,000,000 shares of Second Round financing of Common Stock of Astra Logics Inc., Hong Kong, at a price of US$7.00 per share, payable in cash. The offer, which has been unanimously approved and recommended by Astra Logic’s Board of Directors is being made pursuant to the agreement between the two companies.

The tender offer, which is currently scheduled to expire at 12:00 midnight EST on Thursday, June 1st, 2017 (unless extended) is subject to the tender by Astra Logic’s shareholders and would represent a majority of the outstanding shares on a fully diluted basis, as well as other customary conditions.

Astra Logics, Inc. aims to become a leader in advanced drug delivery systems with Graphine Oxide being the key component. After extensive research and testing the firm’s proprietary protocols are now nearing completion of initial phase clinical trials in Hong Kong. Ken Holland, Head of Corporate Affairs for Astra Logics said, “When completed, this tender offer provides the company with substantial cash reserves allowing for continued product development. Institutional sponsorship is critical to strengthening our market position for the long term”.

S-Acquisition Corp’s Director of Bio-Pharm Transactional Services, Mr. Craig Kirkman, stated “Astra Logics’ unique delivery platform offers tremendous upside potential in a sector providing boundless opportunity for return. Our firm shares the same long-term vision and commitment necessary to allow the company to progress”.

About S-Acquisition Corp.
S-Acquisition Corp. is a global corporate advisory with expertise in mergers and acquisitions, capital markets, financial restructuring, valuation, and strategic consulting. The firm serves corporations, institutions, groups and individuals worldwide and has its headquarters located in the United States.

About Astra Logics, Inc.
Astra Logics, Inc. is an independent biotech firm based in Hong Kong with a focus on the research and development of Nano-particle, bio-therapeutic drug delivery systems for the treatment of cancerous tumors, in particular lung cancer. The firm’s core objective is to deliver highly innovative cancer therapies that currently have few, if any, effective treatment options.

Contact-Details: S-Acquisition Corp.

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Study: New laser-based imaging technique can detect inflammation more accurately

GERMANY, Mar-30-2017 — /EPR Biotech News/ — Ulcerative colitis and Crohn’s disease are the most common inflammatory bowel diseases (IBD). Globally, more than 4 million people suffer from recurring inflammation of the intestinal mucosa. To date, non-invasive methods have not been able to detect these forms of IBD reliably. Researchers at the University Hospital Erlangen (Germany) have now shown for the first time how Multispectral Optoacoustic Tomography (MSOT) can more reliably detect early stages of inflammation when compared with other non-invasive diagnostic methods. These results have recently been published in the New England Journal of Medicine.

Evaluating the inflammatory activity of the intestines early and accurately helps to prevent complications associated with IBD and guide an optimal therapy regime. Currently, doctors frequently rely on an invasive endoscopy procedure to assess the intestinal mucosa of patients with IBD. Additionally, non-invasive imaging methods are increasingly used in the clinic. For example, ultrasound allows clinicians to examine the structure, thickness and blood perfusion of the intestinal wall with changes in perfusion patterns indicating an onset of inflammation.

“With the MSOT procedure, we additionally use laser light, by which we can detect inflammation earlier than previously possible with ultrasound”, explains Prof. Dr. Maximilian Waldner, Professor at the University Hospital Erlangen. “The earlier we detect signs of an upcoming flare – i.e., a change in blood content – the quicker we can react and start a preventive treatment”. The MSOT technology was developed by iThera Medical in Munich, and was first used on IBD patients last year.

The researchers of the University Hospital Erlangen have recently published their results in the renowned New England Journal of Medicine. “We examined 108 patients with Crohn’s disease using the MSOT technology and compared the results to established non-invasive diagnostic procedures as well as endoscopy and histology”, says Prof. Waldner. “We were able to demonstrate that hemoglobin values in the tissue measured with MSOT indicate very accurately the inflammatory activity in the intestines. The method appears to be superior to other non-invasive procedures, as MSOT for the first time was able to detect even low levels of inflammation without having to perform endoscopy”.

Dr. Ferdinand Knieling, a physician at the University Hospital Erlangen, adds: “We are hoping that this principle can be applied to many applications and, in particular, also be used to enable safe evaluations of children and adolescents. With this new examination method, many of the currently invasive procedures might become obsolete.”

In optoacoustic imaging, the physician scans the intestines transabdominally through the skin, applying pulsed laser light in the near-infrared region. The energy of the light absorbed in tissue is converted into acoustic signals which are then acquired by an ultrasound detector. Christian Wiest, CEO of iThera Medical, comments: “MSOT is a new diagnostic imaging modality that can detect changes in tissue composition associated with a variety of diseases, without the use of contrast agents. The technology has already been applied in other clinical feasibility studies, e.g. for the detection of melanoma metastasis in sentinel lymph nodes or for the assessment of suspicious breast lesions”.

The results of the IBD study at the University Hospital Erlangen were published on March 30th 2017 in the New England Journal of Medicine (Volume 376, Issue 13, pg.1292-1294).

SOURCE: EuropaWire

Nu-Tek Bioscience Announces study comparing various Soy and Pea Peptones and Yeast extracts on Nov. 14, 2016

nu-tek-bioscience-study-comparing-various-soy-and-pea-peptones-and-yeast-extracts

Allergan and Animal free Peptones for the use in culture media

Minnetonka, MN, 2016-Nov-14 — /EPR Biotech News/ — Today at Nu-Tek Bioscience announced the completion of an outside study comparing various protein sources on the enhancement of Cell growth using E. Coli. The study was completed by The University of St. Thomas.

Nu-Tek HSP (Hydrolyzed Soy Protein) and HPP (Hydrolyzed Pea Protein) peptones showed the least strain dependent variability in growth performance. In contrast to competitor peptones showed poorer performance. This has been an ongoing issue with media developers to minimize the variation from lot to lot in Peptones. Nu-Tek Bioscience has developed a technology that promotes reduction in variability.

Blending HPP (Nu-Tek’s Bioscience Hydrolyzed Pea Protein) with a weakly performing peptone supports growth of the weakly performing peptone to the level of performance of the HPP alone. The study has shown excellent growth performance results that compare favorably with soy peptones, pea peptones and yeast extracts. In addition, peptones have been shown to improve fermentations versus yeast extract “only” growth media.

Nov. 14, 2016 Availability
Nov. 14, 2016 is an update driven by customer feedback and is part of Nu-Tek Bioscience’s commitment to deliver the latest industry updates. Nov. 14, 2016 is available for immediately download at www.nu-tekbioscience.com

Founded in 2008, Nu-Tek Bioscience LLC is the worldwide manufacture and developer of specialty Peptones that have been designed to enhance Cell growth. The company offers a wide range of Peptones and Yeast Extracts designed to promote increased cell growth.

For more information, press only:
Cyndi Mueller
952-936-3604
cmueller@nu-tekbioscience.com

For more information on Nov. 14, 2016:
www.nu-tekbioscience.com

GenQual and R-Pharm collaborate to deliver predictive diagnostics for novel anti-IL-6 antibody for autoimmune diseases

Seattle, WA, San Francisco, CA and Moscow, Russia, 2016-May-25 — /EPR Biotech News/ — R-Pharm and GenQual are pleased to announce a new collaboration focused on the development of novel predictive diagnostic tools in the area of Rheumatoid Arthritis and Autoimmune diseases.

The GenQual proprietary real-time PCR platform, when applied to the genes that are involved in the manifestation of several autoimmune diseases, allows us to detect and assess single nucleotide polymorphisms. Here, allelic determination is used as potential predictor of the treatment response by the novel anti-IL6 antibody, which is currently in development by R-Pharm.

GenQual Founder and CEO Jonathan Mirich said, “This partnership is exciting for GenQual as we advance in our goal to deliver predictive diagnostic tools for the treatment of autoimmune disorders. We are very excited about the possibilities in this space and are thankful to have quality partners in R-Pharm.”

R-Pharm CEO Vasily Ignatiev indicated the importance of the Autoimmune diseases as an area of the development and growth for R-Pharm, as well as the development of novel diagnostic tools aimed to increase the level of predictive response and efficiency of the upcoming treatment paradigm.

About GenQual
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications.  Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level.  GenQual is a privately-held corporation based in Seattle, WA area, USA.

About R-Pharm
R-Pharm is a private Russian pharmaceutical company founded in 2001. It employs over 3,500 highly qualified specialists in 60+ branches. R-Pharm operates in Russia and CIS, USA, Germany, Japan, Turkey/MENA.

The company is involved in R&D, manufacturing (finished dosage forms, biotech and chemical APIs), marketing, sales and distribution of innovative pharmaceutical products in hospital/specialty care therapeutic areas.

R-Pharm collaborates with major international pharmaceutical companies and universities in the fields of drug discovery, development, clinical trials, manufacturing and commercialization.  The company operates several  GMP compliant manufacturing sites in Russia and Germany, research, BD/licensing and marketing affiliates in Japan, Germany, Turkey and US.

Marketed portfolio and pipeline features drugs used in oncology, hematology, autoimmune diseases, HIV, HCV, neurology, diabetes, cardiology, as well as antibiotics, contrast media and anesthesia agents.

Contact

R-Pharm
info@rpharm.ru
www.r-pharm.com/en/

 

GenQual

info@genqual.com
206.659.7825
www.genqual.com

 

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Nu-Tek Bioscience Announces Availability of Pea Peptones

Allergen free Peptones for the use in probiotic cultures

Minnetonka, MN, 2016-May-10 — /EPR BIOTECH NEWS/ — Nu-Tek’s Pea Peptone is an excellent alternative to Dairy and Soy Peptones for the production of probiotic cultures. Consumers with known food allergies rely on ingredient labeling for guidance. An Allergen Control Plan is a critical component of a food ingredient manufacturer’s safety initiatives. It not only protects the health and confidence of the consumer, but also the reputation and financial success of the company.

An advantage of allergen management strategies include ingredient selection that eliminates allergens without negatively affecting the performance of the product. Formulating growth media using Nu-Tek Pea Peptone provides such an advantage. Nu-Tek Pea Peptone HPP-A is an excellent source of natural nitrogen and necessary growth factors needed for optimum probiotic culture fermentations.

Our Kosher Pea Peptones are obtained through enzymatic hydrolysis of Animal free and Non-GM pea protein. Pea protein hydrolysates do not require special allergen labeling. Independent university trials have shown excellent growth performance results that compare favorably with soy peptones. In addition, peptones have been shown to improve fermentations versus yeast extract “only” growth media. Today at Nu-Tek Bioscience announced immediate availability of Pea Peptones, enabling developers of probiotics to either enhance their current culture growth rate.

Pea Peptones

Pea Peptones Availability
Pea Peptones is an update driven by customer feedback and is part of Nu-Tek Bioscience’ continuing development of new technologies.

Founded in 2008, Nu-Tek Bioscience LLC is the worldwide manufacture and developer of specialty Peptones that have been designed to enhance Cell growth. The company offers a wide range of Peptones and Yeast Extracts.

For more information, press only:
Cyndi Mueller
952-936-3604
cmueller@nu-tekbioscience.com

For more information on Pea Peptones:
www.nu-tekbioscience.com

Austrianova expands its business area

SINGAPORE, January 26, 2016 — /EPR BIOTECH NEWS/ — Austrianova announced today that, having completed the set up of austrianova logoits new GMP facility, it is now offering clients a GMP cell banking (Master Cell Bank and Working Cell Bank) as well as a “Fill and Finish” service for cell therapy products, in addition to its encapsulation services and technology. Austrianova is able to offer the production of Master Cell and Working Cell Banks (MCB and WCB) at the size scale required for early (phase 1 and 2) stage clinical trials at highly competitive prices using its state of the art isolator based production facility, assuring that the highest quality standards are adhered to. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells. MCB’s and WCB’s are required for all cell therapy products such as stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc. Similarly, many companies, including those developing stem cell lines and products, are seeking high quality economic fill and finish for relative small lots.

“We see this as a natural add-on to our already established Cell-in-a-Box® cell encapsulation technology for which we have recently set up a GMP manufacturing facility in Thailand. This kind of MCB and WCB production as well as “Fill and Finish” services for cells are, however, stand alone services. Although these services are generally available to all customers, they should allow start up companies and academic based cell products, vaccines etc to enter clinical trials in a quality assured manner but at lower cost that other, more conventional, cell banking companies offer” stated Walter H. Gunzburg, Chairman and CTO of Austrianova.

“In addition to our state of the art facility, Austrianova offers services that comply with major international regulatory agencies using a customized German/Swiss based quality assurance system. Our team has many years experience with regulatory agencies around the world and has taken cell therapies into clinical trials” said Brian Salmons, CEO.

More information about the GMP4Cells cell banking but also the Cell-in-a-Box® and the related Bac-in-a-Box® encapsulation services can be found on our newly revamped website www.austrianova.com.

About Austrianova:
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability for extending storage under lyophilized conditions and protection in stomach acid.

Austrianova Singapore Pte Ltd,
#05-19 Synapse,
3 Biopolis Drive,
Singapore 138623
Tel +65 6779 3867
Fax: +65 6268 4671

Austrianova Thailand Co., Ltd,
141 INC2 Building D, Room 401-404
Thailand Science Park,
Paholyothin Road, Klong 1,
Klong Luang, Pathumthani 12120,
Thailand

www.austrianova.com

###

ISOLATOR

 

BOC Sciences Released Analytical Support Services

Long Island City, New York, January 15, 2016 — /EPR BIOTECH NEWS/ — Thursday of this week (January 14, 2016), BOC Sciences officially launched its analytical support service, aiming to provide all-round custom services on the base of its present services in pharmaceutical field.

BOC SCIENCES LOGO

The analytical service of BOC Sciences covers a wide range in almost every aspect of drug discovery from impurities identification, purity level testing, to right equipment suggestion for compound preparation with the aim of providing the best solutions for research conduction and maximizing the outcome with less waste in both time and cost.

Analysis service on inspecting the quality of compounds before, during, and after researches including their purity level, structure and degradation testing, final chemicals analysis, even involved equipment suggesting are available.  “The launch of analytical service is an upgrade of the present customer services like drug design, compound manufacturing, but making the analysis outstand to meet pure needs in this aspect, with which the companies that carry out researches in a single direction can benefit from our comprehensive expertise network.” Said Daylen, the director of the newly funded business department, “and we will continue to optimize our professionalism in the field to serve more clients in such tailored needs.”

Besides, the analytical support (http://www.bocsci.com/analytical-support.html) additionally includes but not limited to mass spectrometry, nuclear magnetic resonance, and X-ray crystallography. Other technologies like chemistry synthesis and bioconjugation involved analysis needs can be also met at BOC Sciences

With the development of pharmaceutical industry, numerous studies and researches on material and new formulation are undergoing, the appearance of BOC Sciences’ analytical support services can be considered as an outsource route for companies that are not willing to spare more time and budget on some sub-matters, and such custom services can contribute to a purer research with no further distraction while obtain the highest level of expertise in related matters.

This form of analytical service will get furtherly developed as the general environment put more emphasis on the idea that professional problems should be done by professional people with the best result while keep efficient.

About BOC Sciences
BOC Sciences (http://www.bocsci.com) is original a chemical supplier on APIs, natural compounds, chiral compounds, inhibitors, GMP products and many other chemicals. But in recent years, the company gradually takes more effort on providing related custom services like synthesis, drug discovery and so on to be a comprehensive products and services supplier in the field.

PR Contact

Linna Green
account@bocsci.com
5166698109

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