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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.

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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.

Via EPR Network
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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.

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

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.

Via EPR Network
More Biotech press releases