Tag Archives: Biotechnology

Innovative Drug Discovery Business, Biosortia Pharmaceuticals, Lands Two Health Care Veterans

Kurt Dieck formerly SVP of Strategy and Business Execution at Cardinal Health, will lead early stage drug discovery business at Biosortia Pharmaceuticals. Dieck was named President and CEO in November 2012 and has quickly identified other key executives, including Dr. Guy Carter, former Natural Product head at Wyeth Pharmaceuticals, as his Chief Science Officer. In conjunction, other collaboration partners have joined the team, including NOAA (National Oceanic and Atmospheric Administration), NCI (National Cancer Institute) and key universities, to strategically accelerate the development of novel drug leads in the therapeutic areas of cancer, infectious diseases, inflammation and neurological disorders. Biosortia Pharmaceuticals has seen promising early results with dozens of novel compounds having already been requested, and are under evaluation with NCI and Eli Lilly.

Dieck has spent nearly 30 years in healthcare, including 18 years at Arthur Andersen as a global equity partner and then 10 years with Cardinal Health, a Fortune 20 public company, as a senior executive; there he worked with a broad spectrum of partners, including brand pharmaceutical manufacturers, throughout the supply chain. Dr. Guy Carter has over 30 years of experience working in pharmaceutical R&D, primarily in the discovery and development of microbial natural products. He previously was the leader of natural products drug discovery at Wyeth Research, as head of the Chemical Technologies Department.

“Kurt and Guy make a great team. Their complementary Pharma experiences and backgrounds create great opportunities to accelerate Biosortia’s objective to become the premier, aquatic natural products company with a primary focus in drug discovery,” says Ross Youngs, Biosortia’s Founder and Chairman. “Kurt and Guy bring a wealth of research and business experience along with deep industry relationships in building successful Pharma partnerships. Everyone involved with this young biotech is excited about the future.”

Industry observers have commented that late-stage R&D pipelines are not providing Pharma with the desired revenue growth the market is expecting. Therefore, large Pharma is evolving the way it performs R&D in order to optimize efficiency and to boost patent cliff defenses. These changes require shifting from relying solely on in-house chemistry-based R&D to acquiring and licensing external technologies and natural products based compounds in various stages of development. Biosortia’s ability to supply novel, highly active and potent compounds with drug-like characteristics will increase the productivity and success rate for Pharma as well as reduce the overall cost of the discovery process. The cost to discover, develop and launch a new drug is estimated to reach nearly $3B per drug by 2015. Biosortia’s business model is designed specifically to support Pharma’s needs.

“With nearly unlimited microorganisms (3.7 nonillion), the aquatic environment and its consortia represent an extraordinary opportunity…a new frontier, to access extremely potent and chemically diverse secondary metabolites with drug-like properties with unique mechanisms of action never researched before,” said Dieck. In describing the opportunity, Dieck goes on to say, “Biosortia is on the cutting edge of natural product discovery
and has the capabilities to deliver on its aspiration. Our powerful natural products research team, led by Dr. Guy Carter, in partnership with NOAA’s Dr. Peter Moeller, a leader in aquatic natural products research, has the experience and know-how to decipher the complex unexplored environment in a very efficient manner leveraging all the current state of the art instrumentation. The need for more efficient and effective approaches to drug discovery has never been more important. Biosortia’s innovative technologies, deep research skills and key relationships will efficiently provide thousands of unique natural products as candidates for drug discovery at a time when Pharma is in critical need for “high quality shots on goal.”

“Aquatic microbial consortia are a rich source of metabolically active organisms including microalgae, bacteria, fungi and their secondary metabolites,” states Carter. “Owing to the competitive nature of their habitat, chemical investigations of microbial consortia reveal unique structurally diversified natural products that are responsible for signaling and self-defense that have potential as therapeutics with novel mechanisms of action. Since they have been pre-optimized by nature, these compounds are typically closer to a drug candidate than a synthetic lead, thus requiring less optimization and shorter time when found as ‘hits’ in screening programs.”

The team has also focused on agreements with strategic collaboration partners as vital components to the strategy. Biosortia has recently entered into several collaboration agreements with NOAA, Analyticon and exclusive harvesting relationships, just to name a few. Several others will be advanced by the end of January. Biosortia’s cooperative research and development agreement (CRADA) with NOAA’s Center for Human Health Risk at Hollings Marine Laboratory provides a 5-year framework for research and development regarding the analysis and purification of novel bioactive compounds. According to NOAA’s Technology Partnerships Office, “Success will result in the commercial development of new and unique chemical compounds from the sea which have benefits to human health, either through disease prevention or new treatments for disease.”

Dr. Peter Moeller, NOAA’s Research Scientist who leads the Toxins Natural Products Program stated after analyzing fractions of Biosortia’s biomass, “Coupling NOAA’s mission of characterizing toxins affecting environmental and/or human health with Biosortia’s drug discovery focus turns one man’s toxin into another’s chemotherapeutic. The microorganisms analyzed in the Biosortia biomass identified more unique activity than I have seen in my 30 year career. The volumes achieved from a single harvest delivered an equivalent of 30 years of accumulation. This could materially change the landscape for natural products drug discovery research.”

As of December 31, 2012, Biosortia has identified more than 30 bioactive candidate compounds (hits) from a fresh water eutrophic lake consortium. Therapeutic areas of focus include treatments for cancer, infectious diseases, inflammation and neurological disorders. In addition, more than a dozen of its patent protected compounds are in initial evaluation stage within Eli Lilly’s Open Innovation Drug Discovery Program.

Dieck states, “Looking forward, it is with great optimism. We have a great team built around mutual respect, deep experience, and a desire to succeed and make a difference. We are aligning with the right partners and collaborators to execute our strategy with speed and discipline to provide Pharma with much high quality & diverse compounds vs. “me-too” drugs than they have had in the past 10 years. We are excited about what this company can accomplish, not only for its shareholders but also for the millions of people who have been diagnosed with various forms of chronic diseases who are looking for Pharma to identify better ways to help them extend their lives or live a more productive life. Biosortia can play a big role in identifying compounds that can help Pharma achieve these goals. I am looking forward to the challenge and opportunity to build an industry leading drug discovery company.”

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GenQual Announces Initial Closing Of Its First Preferred Equity Funding Round

GenQual is pleased to announce initial closing of its first preferred equity round. Financial terms were not disclosed. This inaugural funding round allows GenQual to pursue proof-of-principle testing for its companion diagnostic approach for IL-6 mAb and other JAK/STAT inhibitors for autoimmune diseases and oncology indications. GenQual aims to prospectively identify responders for clinical-stage therapeutics to improve drug trial response rates and improve chances for drug approval. The round remains open for further funding.

GenQual Founder and CEO Jonathan Mirich said, “This funding round allows GenQual to pursue its business development goals to deliver companion diagnostics for very expensive IL-6 monoclonal antibody treatment for autoimmune disease, chiefly rheumatoid arthritis, as well as certain oncology indications. It allows us to extend collaborative agreements for proof-of-principle testing. We are very excited about the possibilities in this space.”

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 the Seattle area.

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Website Recognizes Benefits of Biotech Crops

A new website by The United Soybean Board (USB) highlights the important role biotechnology plays in allowing U.S. farmers to continue to meet the world’s food demand as well as ensuring our environment and food supply remains as safe as ever. Whether you know it as biotech, genetically modified or GM—the technology that allows farmers to grow more per acre with fewer inputs plays a critical role in feeding our growing world.

Website Recognizes Benefits of Biotech Crops

Biotechnology allows researchers to select the desired characteristics in a variety of seeds and crops, resulting in improved nutrition, increased pest and disease resistance and greater crop yields. This technology enables farmers to generate a sustainable supply of food, feed and fuel for customers here at home and abroad.

Click here for additional information on biotechnology.

About the United Soybean Board
The United Soybean Board (USB) represents a group of volunteer farmer-leaders administering a U.S. soy research and promotion program known most commonly as the “soybean checkoff.” Through the soybean checkoff, U.S. soybean farmers invest a portion of their sales in research and promotion to provide food, feed, fuel and fiber to the world. By building demand for such things as soy biodiesel, soybean meal, soybean oil, soy exports and more, USB and the soybean checkoff help provide profit opportunities for all U.S. soybean farmers.

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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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LC Sciences First miRNA Microarray Service Provider to Offer Plant MicroRNA Database (PMRD) Probe Content

Taking full advantage of its flexible µParaflo® Biochip Technology, Houston based LC Sciences today announced immediate availability of probe content from the newly created Plant MicroRNA Database (PMRD) for their microRNA (miRNA) microarray customers . This announcement comes immediately following a publication in Nucleic Acids Researchintroducing the public database 1 . The PMRD integrates available plant miRNA data deposited in other public databases, gleaned from the recent literature, and data generated by the database organizers. It is freely available at http://bioinformatics.cau.edu.cn/PMRD.

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 means made-to-order microarrays can be produced, delivering the most up-to-date research tools to researchers; in this case, the PMRD content.

In total, there are 8433 miRNAs collected from 121 plant species in PMRD, including model plants and major crops such as Arabidopsis, rice, wheat, soybean, maize, sorghum, barley, etc. For Arabidopsis, rice, poplar, soybean, cotton, medicago and maize, the possible target genes for each miRNA with a predicted interaction site are included in the database. This represents a significant increase in content vs plant miRNA microarrays based solely on the miRBase content.

The public miRBase sequence database 2 serves as the primary probe content for many commercially available miRNA profiling microarrays (http://microrna.sanger.ac.uk/sequences/). 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, in a rapidly evolving field such as miRNA research, it is important to have a flexible system that can keep up with all the newly discovered and predicted sequences. Pre-spotted glass slide arrays immediately go out of date whenever new miRNA database versions are released. LC Sciences’ microarrays ensure scientists have the most complete picture of miRNAs expressed in their experimental samples.

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Enabling microRNA Discoveries – LC Sciences Tops 100th Customer Publication

LC Sciences announced today the publication of the 100th peer-reviewed study by one of its customers using the company’s microarray service for analyzing microRNA (miRNA) expression profiles and for discovery of novel small RNAs. These studies, by leading researchers in the field, contribute to a fast growing body of knowledge defining this recently discovered class of regulatory RNAs.

To date, miRNAs have proven to be extremely important part of the gene expression regulation mechanism. Expression profiling and functional studies conducted so far indicate that miRNAs participate in the regulation of almost every cellular process investigated and this is evident in the amount of relevant findings being translating into published reports.

The publications to date by LC Sciences’ customers span a diverse range of study areas, including cancer research, neuroscience, cardiovascular research, MicroRNA Publications reproductive biology, plant science, virology, stem cell research, immunology, and small RNA discovery. Their miRNA profiling service has provided a tool for many researchers to explore and examine a wide assortment of miRNA cellular networks and the resulting publications are often the first description of miRNA activity in these systems.

LC Sciences’ miRNA profiling service, powered by its µParaflo® microfluidic technology, provides quick, reliable, fully analyzed data enabling researchers to immediately move forward with innovative research, and publish their results faster. Microarray results require extensive validation prior to publication. The speed with which researchers using this miRNA profiling service have published their discoveries demonstrates the high-quality and reliability of these results.

The 100th study, entitled “MicroRNA-146a feedback inhibits RIG-I-dependent Type I IFN production in macrophages by targeting TRAF6, IRAK1, and IRAK2” appeared in the September issue of The Journal of Immunology and was one of a group of articles published recently by LC Sciences’ customers describing miRNA involvement in the immune system. Researchers at the National Key Laboratory of Medical Immunology, China studied the fine tuning effect that miRNA has on inflammatory response to viral infection and even propose a new mechanism for the evasion of innate immune control by viruses. MiRNA microarray data revealed, and real-time quantitative PCR confirmed, many up-regulated miRNAs in vesicular stomatitis virus (VSV) infected mouse macrophages. Specifically miR-146a expression was significantly up-regulated. Further studies revealed that miR-146a negatively regulated VSV-triggered interferon production (which is necessary to exert feedback control over inflammation) promoting VSV replication in macrophages. The identification of miRNAs and a better understanding of their expression in response to various stimuli/pathogens may reveal that miRNAs offer multiple new therapeutic targets/strategies for fine tuning the immune response to treat and prevent of a number of inflammatory diseases.

“We are very excited about the announcement of the 100th peer-viewed publication by one of our customers,” says Chris Hebel, VP of Business Development at LC Sciences. “MiRNA has become a very hot area of research and many scientists would like to be the first to describe the mechanism of miRNA as it relates to their field of study. We are happy to provide a first look into this exciting new field for them and are proud that our technology has been a part of such groundbreaking work”.

About µParaflo® Technology – The µParaflo® technology is a microfluidic platform for in situ parallel synthesis of biomolecular chips and miniaturization of bioassays including binding and enzymatic reactions. This unique platform technology is based on a new class of three-dimensional pico-liter microfluidic reaction devices, and a digital light controlled synthesis method that employs conventional oligonucleotide or peptide synthesis chemistry; a completely programmable process. The seamless integration of these multidisciplinary technologies enables a significant advance in parallelization, miniaturization, customization, and automation.

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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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LC Sciences’ Versatile Microfluidics Chip Technology Extended to Target Selection Applications

LC Sciences has announced the availability of a custom target enrichment service for next-generation sequencing applications. LC Sciences now provides a service for Target-Specific Selection of a defined genomic region (such as Mbp region at a specific location, suspected cancer regions, SNP regions, regions for genomic comparisons) or RNA sequences (such as sets of transcriptome sequences known f r o m previous screening experiments, mRNAs, and miRNAs). This new service enables researchers to take full advantage of new “next-generation” high throughput sequencing technologies.

It is clear that these new sequencing technologies can be more effectively utilized for systematic studies of genetic variation by targeting certain specific regions (subsets) of complex genomes. Essentially, our service achieves more coverage and deeper sequencing by reducing sample complexity and focusing reads on the areas of interest.

LC Sciences µParaflo® technology’s unique combination of advanced microfluidics and innovative synthesis chemistry provides a robust synthesis process which is necessary to achieve high quality selection and the flexibility to handle almost any target selection project. This technology has been used to produce custom sequence microarrays [Nucleic Acids Res. 2004,32,5409] and custom designed oligonucleotide mixture libraries (OligoMix®) [Nature. 2004,432,1050] since 2003 and is now particularly well suited to providing target selection solutions. The versatility of the technology makes it a good fit for the diverse needs of researchers embarking on new high-throughput sequencing projects.

“It’s really the flexibility of the technology that sets it apart f r o m others”, says Dr. Christoph Eicken, Head of Technical Services, Microarrays. “First, this is a completely custom synthesis technology, meaning almost any selected genomic region of any species and all known RNA transcripts can be targeted. Second, target selection may be achieved by hybridization using complementary capture probes immobilized on surface or by in-solution hybridization. By altering the target selection approach we take, we can address the widely varied needs of each individual sequencing project. With our help, researchers can tailor design the target selection process based on the specificity, coverage, selection resolution and throughput requirements of their particular project.”

LC Sciences’ microarray based approach utilizes thousands of custom oligonucleotide sequences which are synthesized in situ on a programmable high density microfluidics chip as capture probes designed to target specific regions of interest in any genome (or transcriptome). Samples are hybridized to the chip, undesired sequences are washed off and the captured target sequences are recovered by eluting them f r o m the chip. The selected target sequences are ready for high-throughput sequencing or further processing.

When target selection in-solution makes sense, this flexible chemistry can directly synthesize biotinylated or phosphorylated oligonucleotides (capture probes) that are designed to target specific genomic/sequence regions of interest. After hybridization with a sample, magnetic beads are added and the capture probes are affinity linked to the beads. The captured target sequences are separated f r o m other sequences by washing the beads after which the target sequences can be recovered. Alternatively, the oligonucleotides (OligoMix®) may be immobilized on beads prior to target selection, again depending on the needs of the particular project.

LC Sciences currently offers its Target-Specific Selection application as a service, as it has successfully done with other applications of the µParaflo® technology such as miRNA profiling, small RNA discovery, kinase profiling and epitope mapping with peptide arrays, and others.

“We find that researchers would prefer to spend their valuable time focusing on their research, not figuring out how to make successful use of someone else’s new technology”, says Chris Hebel, Director of Business Development. “We offer a comprehensive solution: customers tell us their experiment goals, send us their samples and we provide the material ready for sequencing. There is no reason they need to become target selection experts to keep their research moving forward. We have already developed methods to design optimized hybridization probes and suitable experimental procedures and conditions for different sample types, such as miRNA, small RNA, or genomic DNA samples, on different sequencing platforms. We can even perform the high-throughput sequencing and deliver the results, as not all labs have access to next-generation sequencers yet.”

More information about LC Sciences’ Targeted Sequencing Sample Enrichment Service and the µParaflo® technology is available at:http://www.lcsciences.com/targeted_sequencing.html.

About LC Sciences – LC Sciences is a genomics and proteomics products company offering a comprehensive line of DNA, RNA, and peptide microarrays for nucleic acid/protein profiling and functional analysis, biomarker-discovery, novel drug screening, and the custom development of miniaturized assay devices for diagnostics and biosensing applications. Based on the µParaflo® microfluidics technology, LC Sciences’ innovative products and services offer significant flexibility and customization capability for rapidly evolving, diverse customer needs. In an era of rapid technological advancement, LC Sciences offers service products which enable efficient one-stop solution for assays of DNA, RNA, protein, enzymes, antibodies, or small molecules. LC Sciences also provides unique synthetic DNA and RNA products such as OligoMix®, generated using their microfluidic biochip synthesizer. These innovative products drive synthetic biology, systems biology and sequencing applications by reducing the cost and increasing the speed of highly multiplexing large-scale nucleic acid and protein engineering experiments.

More information about LC Sciences is available at www.lcsciences.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.

Via EPR Network
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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.

 

Via EPR Network
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