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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.

Via EPR Network
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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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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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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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