Monthly Archives: May 2009

Biomedical Engineering, Biopharmaceutical, Biotech, Biotech Products, Biotech Services, Biotech Solutions, Biotechnology, Genetics, Pharmaceuticals

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.

Via EPR Network
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Biomedical Engineering, Biopharmaceutical, Biotech, Biotech Products, Biotech Services, Biotech Solutions, Biotechnology, Genetics, Pharmaceuticals

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.

Via EPR Network
More Biotech press releases