Senior Director of Biotechnology at Catalent To Lead Workshop on Immunogenicity for Biologics 2009
on: July 22, 2009, 10:48 am
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
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.
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.
Contact Details: Dan Dunlop, Jennings
Peggy Albertson, Jennings