Category Archives: Genetics

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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LC Sciences Launches Online Searchable Knowledgebase

LC Sciences, LLC, a leading provider of microRNA analysis services, today announced the launch of a new online searchable knowledgebase that researchers can use to locate technical information on the company’s website. This announcement comes on the heels of the launch of LC Sciences’ re-designed company website last week. The knowledgebase contains technical information in the form of application notes, technical bulletins, customer publications, presentations, reviews of seminal publications in the field, etc. This documents database contains over one thousand entries and encompasses a wide range of research fields; from plant science to neuroscience. Additionally, all entries have been carefully meta-tagged to improve search results.

“Having served the microRNA research community for the past nine years, we’ve accumulated quite a large library of reference documents such as application notes and related customer publications. This new resource offers the community a simple, user friendly search interface that makes it easier for them to locate the information they’re looking for within that library.” – Chris Hebel (Vice President of Business Development, LC Sciences)

The knowledgebase is freely accessible to all at: http://www.lcsciences.com/Knowledgebase/

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Microtissues® Inc. and Sigma-Aldrich® Sign Worldwide Supply and Distribution Agreement for the 3D Petri Dish®

Microtissues® Inc. announced today the signing of a Supply and Distribution Agreement with Sigma-Aldrich® Corporation (Nasdaq: SIAL) for the worldwide sales and marketing of the 3D Petri Dish®, a new technology for the culture of living cells in three dimensions (3D). Invented at Brown University, the 3D Petri Dish® maximizes cell-to-cell interactions critical for replicating the function of natural tissues and organs. Shown in numerous peer reviewed papers to work with over fifty different cell types, including cell lines, primary cells and stem cells, the 3D Petri Dish® has applications in cancer research, drug discovery, toxicity testing and regenerative medicine.

“Researchers are rapidly recognizing the importance of 3D cell culture and its ability to reliably mimic in vivo function” said Brian Morgan, Director of Business Development, Microtissues® Inc. “The 3D Petri Dish® creates a natural 3D environment without artificial scaffolds and we’re excited that this distribution agreement will bring our unique and innovative line of products to the worldwide research community.”

Unlike the conventional plastic Petri dish where cells are grown as a thin layer on the surface of the dish, the 3D Petri Dish® forms 3D aggregates of cells. Spheroid size is controlled by the number of cells seeded and hundreds of uniform sized spheroids are formed in a single pipetting step. Spheroids are formed in a well ordered array in a stable platform suitable for long term culture. All spheroids are positioned on the same optical plane making them easy to image (phase contrast, fluorescent). Spheroid size is controlled by the number of cells seeded and a mixture of cells forms mixed spheroids, suitable for investigating tumor-stroma interactions. Spheroids can be grown from single cells, applicable to the study of cancer stem cells. For histology, Western blots and RT-PCR, spheroids are harvested by simply inverting the 3D Petri Dish®. No need to dissolve or digest the gel. The 3D Petri Dish® is a new fundamental tool for the world wide industry of life sciences research.

About Sigma-Aldrich®: Sigma-Aldrich® is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich® customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich® is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich®, please visit its website at www.sigma-aldrich.com.

About Microtissues® Inc: Microtissues® Inc. is a privately held company located in Providence, RI, advancing technologies and applications of 3D cell culture. Microtissues®, Inc.’s products are designed to serve the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. Microtissues®, Inc. has an exclusive worldwide license from Brown University to US and international patent applications on the 3D Petri Dish®. For more information on Microtissues®, Inc., please visit www.microtissues.com.

Sigma-Aldrich and Sigma are trademarks of Sigma-Aldrich Co. LLC registered in the US and other countries. Microtissues and 3D Petri Dish are registered trademarks of Microtissues, Inc.

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Is it a Moment or an Abuse: the Boom of iPSCs Research after 2012 Medicine Nobel Prize

On Creative Biomart website, we can read a report about the 2012 Nobel Prize in Physiology or Medicine regarding the two winners. They bring hope for organ or tissue repair for human or even for rejuvenation, i.e. for long life through induced pluripotent stem cells (iPSCs).

Since the first appearance in 2006, iPSCs became the hit and focus. But there are still lots of unknowns waiting for us before achieving the ideal status. Thus, numerous scientists, researchers and businessmen are struggling and investing for that goal. Here are some examples:

On Dec. 5, 2012, Roche (SIX: RO, ROG; OTCQX: RHHBY) and the Innovative Medicines Initiative (IMI) announced today the launch of StemBANCC, a new academic–industry partnership that unites ten pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this ground-breaking new technology to develop human disease models and enhance drug development.

On Oct. 29, 2012, on the PANS Journal there is an article about Cartilage tissue engineering using differentiated and purified induced pluripotent stem cells.

On Oct. 4, 2012, on Cell Stem Cell, there is a report with the title be Genome Sequencing of Mouse Induced Pluripotent Stem Cells Reveals Retroelement Stability and Infrequent DNA Rearrangement during Reprogramming.

On Jan. 30, 2012, on the PANS Journal, there is a report about modeling hepatitis C virus infection using human induced pluripotent stem cells, which make the individual and tailor therapy further.

Above are only a small part of such studies. People still wonder does it is the moment or an abuse on the iPSCs research. When someone reviewed one of the winners, Shinya Yamanaka, about his opinion on the challenge of iPSCs research, he said, “I have two research directions, the first is to establish human iPSCs bank that comply with clinical application standards. The second is to study the cell mechanism of iPSCs regenerating. And I think the current threat is still to be the safety problem as good research respects both scientific and ethical standards.”

But no one deny the great potential of iPSCs.

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Advinus, SignalChem Start The Multi-Year, Multi-Target Collaboration On New Anti-Cancer Drugs

Advinus Therapeutics, a research-based pharmaceutical development company promoted by the TATA Group, and SignalChem Pharmaceuticals, a British Columbia-based drug discovery company, have started working on 15 programs based on SignalChem’s proprietary Kinase platform for targeted therapies in oncology. Each program is being developed with corresponding diagnostics and tracers for patient selection and biomarkers for follow up offering the right treatment to the right patient at the right time. The companies have received a very high level of interest from pharma companies to license and collaborate on the programs and therefore see a rapid progression to the clinic.

Dr. Rashmi Barbhaiya, CEO and MD of Advinus said– “This collaboration is an exemplary model of polycentric and globally networked innovation for enhancing probability of success, reducing timelines, and focusing on cost-effective partnerships to bring innovative medicines to the market. This collaboration would also leverage leading edge biomedical research of British Columbia research institutions and Advinus’s capabilities and infrastructure to translate biomedical research discoveries into potential life saving drugs.”

Dr. Jasbinder Sanghera, CEO of SignalChem said – “This is a path-breaking partnership that leverages SignalChem’s extensive biology and kinase expertise and Advinus’s end-to-end capabilities of medicinal chemistry, lead optimization, preclinical development and early-clinical development capabilities to rapidly and efficiently advance new anti-cancer drug candidates into human clinical trials.”

The collaboration was announced by B.C. Premier Christy Clark during her visit to India who said – “This is what our Jobs Trade Mission is all about – helping local companies make connections that will allow them to do business in India. We have an innovative technology and life sciences sector in B.C., which has a lot to offer India to support its economic growth. The partnership between Advinus and SignalChem will benefit people around the world.”

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CYTOO Raises 10 M$ (7M€) in Series C Round

CYTOO SA, a company that specializes in cell-based assays, is pleased to announce the closing of a series C funding round of USD 10M (EUR 7M). New investors, Sham and Entrepreneurs Fund (EF), led the round. Existing investors AURIGA Partners and Jacques Lewiner, co-founder and president of the supervisory board at CYTOO, also participated.

CYTOO will use the financing to fully exploit its fast growing business within the global market of cellbased assays and screening, and bring the company up to profitability. Having the potential to lead the next innovation wave in cell-based drug discovery and in vitro toxicology, CYTOO is already on the radar screen of several key industrial actors.

“We are very excited about joining CYTOO as it enters a new phase in its development,” says Olivier Szymkowiak, Chief Investment Officer at Sham. “There is an exceptional opportunity for CYTOO to revolutionize the cell culture for low and high throughput applications,” added Maciek Drozdz, Investment Manager at EF and future Supervisory Board member.

Leveraging its exclusive technology of adhesive micropatterning, CYTOO’s products and services bring robustness, sensitivity and powerful quantification to cell-based assays, high content analysis and cell screening for the life science research market.

CYTOO holds an exclusive worldwide license from the Institut Curie and the CNRS (The French national scientific research center) for the adhesive micropattern patent portfolio, as well as license agreements with Harvard University (USA) and CEA, the largest government-funded technological research organization in France.

“This funding represents a strong achievement in the young history of CYTOO: the company has now the financial means for turning its technological advantage into a commercial success. A shift that the company has already initiated with the commitment of existing investors and our support through the expertise of Jacques Mallet, partner at Auriga Partners” added Franck Lescure, partner at Auriga Partners and member of the supervisory board at CYTOO.

François Chatelain, CEO of CYTOO, commented: “I am excited to lead the company and thrilled to close our series C financing round with a renowned international venture capital investors syndicate. We are welcoming Entrepreneurs Fund and Sham who bring their high level experience in building up successful biotech and medtech companies, we are also pleased with the continued commitment of our historical investors. Together we are looking to move our business and technology onto the next level of growth.”

CYTOO was advised for its capital raising by Silver Ocean Ventures’ Managing Partner Dr John Tchelingerian.

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Michigan Institute of Urology, P. C. to Perform Clinical Trial Using Cellay, Inc’s Same Day OligoFISH® Probes for Prostate Cancer

St. Clair Shores, Michigan and Cambridge, Massachusetts – Michigan Institute of Urology, P. C. (MIU) and Cellay, Inc. today announced that MIU will exclusively perform a clinical trial for prostate cancer using Cellay’s Same Day OligoFISH® probe panel. Data from this trial will be included in Cellay’s premarket approval (PMA) application for submission to the U.S. Food and Drug Administration. This novel, non-invasive screening test is designed to detect chromosomal abnormalities in prostate cells obtained in a urine sample after a digital rectal exam. This investigational use test uses fluorescence in situ hybridization (FISH) technology to detect chromosome gains and losses which have been associated with prostate cancer.

Prostate cancer is the most common cancer in males in the United States, and there are approximately 200,000 new cases diagnosed annually and 38,000 deaths per year. However, due to inaccuracies of the current screening method, the PSA blood test, more than 600,000 invasive biopsies are performed annually. The ability to differentiate non-aggressive from aggressive, metast atic prostate cancers has been a continuous clinical and diagnostic challenge. Cellay expects that the clinical trial will demonstrate that its rapid non-invasive, Same Day OligoFISH® panels will improve diagnosis, prognosis, and treatment using a cost effective, patient friendly assay.

Alphonse M. Santino, M.D., CEO and a Founder of MIU, noted, “MIU is pleased to be the exclusive clinical trial site for Cellay’s Same Day OligoFISH® probe panels for prostate cancer for its PMA submittal. Our relationship with Cellay reinforces our commitment to the people of Michigan to provide the most effective diagnosis and treatment for urological disorders and disease. This is an important relationship for us and our community, since African-Americans are 3.5 times more likely to develop prostate cancer than the rest of the male population. Moreover, this group presents with the aggressive type of prostate cancer at an earlier age with higher rates of mortality.”

“Cellay appreciates that MIU has committed to serve as exclusive site for the clinical trial of our Same Day OligoFISH® probe panels for prostate cancer. MIU’s physicians’ group is recognized as one of the nation’s premier urology practices and sets the standard for diagnosis and treatment of urologic disorders. Cellay welcomes MIU’s support and participation in this novel clinical trial,” said Ed O’Lear, President & CEO of Cellay.

About Michigan Institute of Urology
As one of the oldest and largest sub-specialty Urology practices in Michigan, MIU is dedicated to providing its patients the most up to date, state of the art urologic care. Its specialists have joined MIU from the most respected research universities and hospitals in the United States.

About Cellay
Cellay is a privately held, manufacturer of Same Day OligoFISH® probes for high complexity, physician owned laboratories, which contract with Cellay to manufacture and supply individual probes or multiple probes of the laboratories’ choice pursuant to FDA and Clinical Laboratory Improvement Amendments (CLIA) regulations. Cellay is registered with the FDA.

About FISH
FISH is an established cytogenetic technique that is used to detect and localize the presence or absence of specific DNA sequences on chromosomes. FISH uses fluorescent probes that bind to only those parts of the chromosome with which they show a high degree of sequence complementarity. Same Day OligoFISH® probes were introduced in 2007 and hybridize extremely fast with much higher analytical sensitivity and penetrability in cells and tissues than traditional probes.

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Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

Catalent Pharma Solutions will host a free webinar featuring Principal Scientist, Alan D. Hendricker, Ph.D. The one-hour webinar provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission. The presentation, titled “Leachables and Extractables: Regulatory Context,” will be held on Thursday, March 18th from 2:00 p.m. to 3:00 p.m. EDT. To register for the webinar, please visit: https://www2.gotomeeting.com/register/290022131.

Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

The presentation will be beneficial to all managers, directors, and vice presidents of small and large pharmaceutical companies that are working in product development of all dosage forms. The regulatory documents covered will include those for MDI, DPI, nasal spray, topical, oral and parenteral drug products. Additionally, the webinar will explore other applicable guidance and recommendation documents including: ICH guidance, Product Quality Research Institute (PQRI) recommendations, and EMEA and FDA guidance on genotoxic and carcinogenic impurities. The webinar will conclude with direction on modern approaches to applying this information in an analytical laboratory.

Catalent Pharma Solutions provides expert extractables and leachables services to the pharmaceutical industry with a focus on applying their industry leading scientific, regulatory and compliance expertise to all dosage forms and drug delivery platforms. Participants can expect to learn from Catalent’s expertise in these areas and take away an understanding of regulatory documents surrounding extractables and leachables testings, modern approaches and strategies to these testings, and guidance in analytical laboratory actions.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Gregory T. Bleck, PhD. To Co-Chair Cell Line Development And Engineering Conference

Gregory T. Bleck, PhD., Senior Director of Cell Line Engineering for Catalent Pharma Solutions, will be co-chairing the Cell Line Development and Engineering conference being held in San Francisco, California on February 25-26, 2010.

Gregory T. Bleck, PhD. To Co-Chair Cell Line Development And Engineering Conference

In addition to co-chairing the conference, Dr. Bleck will be presenting “Characteristics of an Effective Mammalian Cell Line Generation Process for Bio-Pharmaceutical Production.” His session will explore how steps in the generation of mammalian cell lines have been optimized to make the process more efficient. Dr. Bleck will also outline certain approaches to improve timelines and throughput. Additionally, data collected f r o m Catalent’s development of more than 200 cell lines, each producing a different antibody or recombinant protein, will be reviewed.

Dr. Bleck received his BS and Ph.D. f r o m the University of Wisconsin-Madison, and performed postdoctoral work at the University of Illinois-Urbana working in the areas of gene regulation and expression, and joined Catalent Pharma Solutions in 1998. At Catalent, he transferred his knowledge of gene expression and transgenic systems to the development and continued optimization of retrovector expression systems and is one of the developers of the GPEx® gene expression technology. Dr. Bleck has published over fifty-five research papers and authored three book chapters. He has seven issued patents and eight patents currently under review.

For more information on Catalent’s broad range of biopharmaceutical development services, go to http://www.catalent.com/development.

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Catalent Solidifies Inhalation Product Development Capabilities With New Offering

Catalent Pharma Solutions has acquired advanced fine powder filling capability, which solidifies Catalent’s position as a leader in development and manufacturing services to the pharmaceutical inhalation sector. With the purchase of Harro Höfliger’s Omnidose filling equipment, Catalent now offers its customers fully scaleable dry powder inhaler (DPI) filling capability. This widely-accepted technology, to be housed in Catalent’s Research Triangle Park, North Carolina facility, provides a flexible platform to reliably support all clinical manufacture through Phase II/III and a scaleable path to higher volume late stage clinical and commercial manufacturing.

The Harro Höfliger equipment is an advanced technology specialized in powder filling for microdosing, in the 1 – 300 mg of powder range, into an array of DPI formats to include both capsule-based and pre-metered blister device formats. This new capability gives Catalent a full range of pulmonary and nasal services, filling a gap in the marketplace for advanced powder filling capabilities. Catalent will now be able to serve as a one-stop-shop for the development of all inhalation dosage forms, possessing both the capital assets and technical experience. This recent addition complements Catalent’s pre-existing automated pMDI infrastructure.

Catalent’s primary location for inhalation product development is in Research Triangle Park, North Carolina where its experienced team offers comprehensive pulmonary and nasal services to help take a product from concept through regulatory approval. Catalent has extensive experience with all pulmonary dosage forms including pMDIs, DPIs, nasal sprays and solutions/suspensions for inhalation. For more information on Catalent’s proficiency in dosage form selection, technology assessment, formulation development, analytical testing and supplying toxicological and clinical trial materials, please visit www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Lead Immunogenicity Course

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will lead a two-day international course on immunogenicity. The course will take place at the Regus Victoria in London on Wednesday, December 2 through Thursday, December 3, 2009.

The interactive course, titled “Introduction to Immunogenicity,” will enable attendees to better understand ways to detect, reduce and characterize unwanted immunogenicity. Additionally, Menendez will aid in interpreting the latest regulatory guidelines, and will assist attendees in formulating a winning strategy to implement in their business immediately.

The sessions will include a formal presentation by Menendez followed by facilitated breakout groups where delegates will be given the opportunity to apply the principles taught in the sections. Case studies, cut-point exercises and protocol workshops will increase the participants’ hands-on experience in developing and validating sensitive and rugged methods to detect and characterize unwanted immunogenicity.

As part of Catalent’s Development and Clinical Services Segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menenedez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Present Course on Bioassays

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be leading a course in Bioassay Method Development and Validation. The course is being offered through IBC Life Science on November 12-13, 2009 in Boston, MA.

Menendez will present a lecture outlining sensible approaches to developing reproducible bioassays using live systems and/or biologically derived reagents. Additionally, Menendez will conduct a workshop on writing validation protocols, and will give participants hands-on experience and case studies, which will add relevance to lecture material as well as create a point of discussion. Targeted audiences are bio-analytical scientists, validation specialists, project management leaders and bioassay scientists involved in bioassay execution. Upon completion of the course, participants will receive a certificate of attendance.

Bioassays are necessary components of the biopharmaceutical development process as functional potency assays during release, stability and formulation studies. The course expands on the importance of the appropriate use of non-analytical techniques that are critical during PK/PD evaluation and measurement of systematic responses to drugs, such as immunogenicity. Also included are immunological and enzymatic methods that are widely used in the detection of biological impurities due to their increased sensitivity and specificity over analytical methods.

As part of Catalent’s Development and Clinical Services segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Catalent Develops New Decorin Molecule Form, Strikes Deal With Euclid

Catalent Pharma Solutions, a leading provider of advanced technologies and outsourced development and clinical services to the global pharmaceutical and biotechnology industry, has announced the development of the Galacorin™ molecule, a proprietary form of the decorin molecule.

Catalent Develops New Decorin Molecule Form, Strikes Deal With Euclid

Catalent combined its proprietary GPEx® gene expression technology, Triplet-FixTM codon optimization technology and advanced scientific capabilities to greatly improve production and secretion of the GalacorinTM molecule in CHO cells. In addition, Catalent has developed a full cGMP production process for the GalacorinTM molecule.

Catalent has reached an agreement to provide the GalacorinTM molecule to Euclid Systems of Herndon, Virginia for an ophthalmic clinical trial. Financial terms of the agreement have not been disclosed. Additionally, Catalent is in the process of seeking partners for other indications.

Catalent’s proprietary GPEx® method of cell line engineering generates high-expressing, genetically stable cells for all mammalian cell types. Antibiotic selection is not needed as part of the procedure; multiple gene constructs can be added individually, at different gene ratios without any requirement for antibiotic resistance markers. The method allows re-production of cellular pathways within mammalian cell types as well as the ability to easily add protein processing enzymes to an already established cell line. Using conventional gene insertion and expression techniques, developing a stable biosimilar production cell line for a target protein can take as long as 18 months. Catalent’s GPEx® technology can overcome the inefficiencies of conventional systems and deliver a stable production cell line for target proteins in as little as 4.5 months.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Lead Workshop on Immunogenicity for Biologics 2009

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be teaching a pre-conference workshop titled “Detection and Characterization of Immunogenicity of Therapeutic Biologics” on Monday, September 7, 2009 in Prague, Czech Republic. The course will focus on the practical technologies used to measure antibody responses to biologic drugs. The pre-conference begins at 10:00 a.m. The Immunogenicity for Biologics 2009 conference will be held on September 8-9, and will include additional discussion on outstanding technical issues, such as standardization and validation of assays as well as the interpretation and application of regulatory guidelines.

catalent

As part of Catalent’s Respiratory, Analytical and Biotechnology group, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

The Immunogenicity for Biologics 2009 conference will cover case studies on assay challenges, FDA and European submissions IgG4 and IgE, pre-clinical and clinical strategies and aggregation. Participants will benefit from practical advice on the design and validation of neutralizing assays.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion in annual revenue. For more information, visit http://www.catalent.com.

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Michael Jenkins, Phd, Of Catalent To Present Their GPEx® Technology At The 2009 BIO Process Theatre Taking Place At This Year’s BIO International Convention

Dr. Jenkins’ talk will focus on Catalent’s proprietary GPEx technology for mammalian cell culture engineering. The 2009 BIO International Convention takes place in Atlanta, GA, May 18-21.

GPEx® Technology

Dr. Jenkins’ presentation is titled “Bench to the Clinic: Using GPEx® Mammalian Cell Culture Engineering to Shorten Timelines, Reduce Risk, and Prepare for Success.” Presentation abstract: The speed at which a recombinant protein product progresses through candidate selection, process development, toxicology production and cGMP manufacturing is of vital importance to both small and large biotechnology companies. Dr. Jenkins will present ways to balance risk, speed and cost as well as ways in which Catalent’s proprietary GPEx technology for mammalian cell line engineering facilitates this process.

Catalent’s Middleton, WI facility is part of the organization’s Respiratory, Analytical and Biotechnology group. The 43,000 sq. ft. site houses process development laboratories, R&D and QC laboratory space, and cGMP product dedicated manufacturing suites withstirred tank bioreactors. Middleton also performs the proprietary GPEx™ technology for the engineering of high expressing, stable mammalian cell lines suitable for cGMP production of biopharmaceuticals.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Two Catalent Scientists, Dr. Tom Feinberg, Director Of Structural Chemistry Services, And Dr. Craig Davies-Cutting, Director Of Research And Development, Will Host A 45-Minute Interactive Workshop At RDD Europe 2009

Two Catalent scientists, Dr. Tom Feinberg, director of structural chemistry services, and Dr. Craig Davies-Cutting, director of research and development, will host a 45-minute interactive workshop at RDD Europe 2009. The conference is designed for academic, industrial and regulatory scientists involved in the development, investigation, preparation and delivery of existing and new therapeutic entities by inhalation. It takes place in Lisbon, Portugal, May 19-22, 2009.

The Catalent sponsored workshop is titled “Formulation and Leachables Considerations in Component Selection for Inhalation Drug Products.” Workshop abstract: Although the range of inhalation delivery devices and components has increased, the rate of new product approvals has not. One explanation is the need to thoroughly explore hardware and formulation compatibility and performance during product development. Additionally, global regulatory expectations have been raised since the publication and dissemination of the Product Quality Research Institute’s Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. This workshop outlines an optimized approach for formulation-device combination screening and selection, and discusses the impact of leachables and materials characterization methods selection on the testing timeline.

Dr. Feinberg and Dr. Davies-Cutting are members of Catalent’s Respiratory, Analytical and Biotechnology group, based in North Carolina’s Research Triangle Park.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Catalent Scientist’s Article Featured by Biotechnology Industry Organization

An article written by Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, was featured in the Biotechnology Industry Organization’s (BIO) March 2009 e-Newsletter. The article, titled “A Guide to Accelerating Bioassay Transfer in the GMP Environment,” highlights important questions and steps to set timelines and prepare for a successful bioassay transfer. Dr. Menendez’s work, along with a number of articles written by industry leaders, is being offered for free download on BIO’s website – www.bio.org.

According to Dr. Menendez, “Setting realistic timetables, creating thorough documentation to transfer bioassays between organizations, and working with a highly qualified CRO are the keys to streamlining the production of biologics and accelerating their time to market.” Her article goes on to provide guidelines to help increase clarity in setting timelines, along with illustrative case studies where delays could have been avoided.

As part of Catalent’s Respiratory, Analytical and Biotechnology group, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Dr. Menenedez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Consistent Development Of Stable-High Expressing Mammalian Cell Lines In Four Months Using Gpex®

Dr. Greg Bleck, the senior director of cell line engineering at Catalent Pharma Solutions, will present later this month at the 12th Annual Pep Talk 2009 Protein Expression Conference to be held in San Diego, C.A., January 12-14, 2009. The conference offers a strong scientific program with more than 120 presentations and poster sessions reviewing the latest research and leading edge technologies in the field.

Dr. Bleck’s presentation is titled “Consistent Development of Stable-High Expressing Mammalian Cell Lines in Four Months Using GPEx®.” Catalent’s proprietary GPEx® method of cell line engineering generates high-expressing, genetically stable cells for all mammalian cell types. Antibiotic selection is not needed as part of the procedure; so multiple gene constructs can be added individually, at different gene ratios without any requirement for antibiotic resistance markers. This allows re-production of cellular pathways within these cell types as well as the ability to easily add protein processing enzymes to an already established cell line. Specific productivities of GPEx® antibody producing cell lines range from 30 -70 picograms/cell/day without upstream process development, while cell lines producing non-antibody proteins as expected have a much broader range of productivities, but if the protein has no secretion problems and does not inhibit cell growth, specific productivities similar to antibodies are obtained.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Dr. Greg Bleck Of Catalent Pharma Solutions, Will Present At The 2nd International Cell Engineering Conference

Dr. Greg Bleck, the senior director of cell line engineering at Catalent Pharma Solutions, will present this week at the 2nd International Cell Engineering Conference to be held in Santa Barbara, C.A., December 2-4, 2008. The conference will include presentations by leading pharmaceutical companies, small biotech organizations, academics, and key technology supply firms covering the latest advancements in cell line development. Special emphasis will be placed on the reliability and reproducibility of the more promising cell engineering techniques. The conference is produced by the Williamsburg BioProcessing Foundation.

Dr. Bleck’s presentation is titled “Generation of Stable-High Expressing Mammalian Cell Lines in Four Months without Antibiotic Selection or Gene Amplification Using GPEx®.” Catalent’s proprietary GPEx® technique for cell line engineering allows high-expressing, genetically stable cells for any mammalian cell type to be produced without antibiotic selection or gene amplification. The lack of selection and amplification allows these master cell bank candidate cell lines to be made in four months, and permits research and development scientists to contemplate new paths for improved expression of their proteins. The candidate cell lines range in specific productivities from 30-95 picograms/cell/day for antibodies and have reached as high as 50-70 picograms/cell/day for some recombinant protein producing cell lines. Cell lines producing over 150 different antibodies and 40 different recombinant proteins have been developed with GPEx®. Data showing the consistency and speed of the technology, as well as the stability and productivity of the cell lines will be presented.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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LC Sciences announced the availability of probe content miRBase 10.0 for their microRNA (miRNA) microarray customers

Taking advantage of its flexible µParaflo™ Chip Technology, Houston based LC Sciences today announced immediate availability of probe content miRBase 10.0 for their microRNA (miRNA) microarray customers. This announcement comes less than a week after Sanger Institute’s update of their sequence database for known miRNAs (miRBase) 1 to version 10.0 (http://microrna.sanger.ac.uk/sequences). As the jump in

version numbers from 9.2 to 10.0 suggests, this update marks a major milestone and features significant changes: 489 new hairpin sequences and 971 novel mature miR and miR* experimentally verified products have been added.

These numbers represent an increase of unique miRNA sequences by 42%. “This exciting increase in data means that researchers using pre-spotted glass arrays with probe content based on versions as recent as 9.1 are missing 49% of mouse, and more than 50% of human sequences, just to give two examples. The other important point is that these sequences are experimentally verified and publicly available data. Unlike with proprietary probe content the researcher has full access and control over the results.” said Chris Hebel, Director of Business Development at LC Sciences.

The importance of this update is emphasized by another aspect of the release: many human, mouse and rat mature miRNAs were renamed and the sequence boundaries changed to reflect the predominant forms identified in recent large-scale cloning studies. The public miRBase sequence database serves as the primary probe content for many commercially available miRNA profiling microarrays. Detection of miRNAs using a microarray offers the opportunity for genome-wide miRNA expression profiling by examining all known miRNA transcripts in a single experiment. However, the continued updating of the database can be problematic for researchers using pre-spotted glass slide arrays as the probe content of the arrays immediately goes out of date whenever a new miRBase version is released. Especially, in a rapidly evolving field as miRNA research it is important to scientists to have the most complete picture of miRNAs expressed in their experimental samples.

LC Sciences miRNA microarrays make use of a microfluidics on-chip synthesis platform, termed µParaFlo™, versus a traditional spotted array based on pre-synthesized oligonucleotides. This on-chip synthesis platform solves the issue of out of date microarrays because made-to-order microarrays can be produced, delivering the most up-to-date research tools to researchers.

In addition to providing much more uniform and reproducible features than a spotted array, on-chip synthesis permits the total customization of content on each individual microarray opening up additional applications such as the discovery of new miRNAs and other small non-coding RNAs.

About microRNA (miRNA)
miRNAs are small non-protein-coding RNA molecules that function as negative regulators of gene expression by base pairing with specific mRNAs. This either inhibits translation or promotes mRNA degradation. About miRBase – The miRBase sequence database is a comprehensive database of miRNA sequence data, annotation, and predicted gene targets and is the primary public repository for these data. Release 10.0 of the database contains 5071 entries representing hairpin precursor miRNAs, expressing 4922 maturemiRNA products, in primates, rodents, birds, fish, worms, flies, plants and viruses (miRBase release summary). miRBase also provides a gene-naming service for assigning official miRNA names to novel miRNAs before they are published. It is freely available to all at http://microrna.sanger.ac.uk/.

About LC Sciences
LC Sciences offers specialty microarray services for nucleic acid/protein profiling and functional analysis, biomarker-discovery, and novel drug screening. Our array service products are based on Atactic Technologies’ µParaflo™ platform technologies that encompass advanced digital chemical synthesis, pico-liter scale biochemical assays, and microfluidic reaction devices containing high density individual 3D chambers.

 

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