(Research Triangle Park, N.C.) Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be leading an interactive pre-conference workshop titled, “Immunogenicity Programs: Not Just Another Box to Check” at the 6th Annual Global Proteins Summit in London, UK. The workshop will be held on June 22 at 12:30pm. The Summit brings together experts from all over the world, presenting the latest developments in protein therapeutics, cell culture expression and immunogenicity.
Dr. Menendez’s workshop is designed to provide a thorough understanding of the scientific and regulatory expectations to detect and characterize antibodies to therapeutic proteins. The presentation starts with a description of the biological mechanism responsible for immunogenicity and by interpreting the recommendations of major regulatory and industry documents. The workshop continues by demonstrating logical pathways to select, standardize and validate correct immunogenicity methods then execute sample analysis. The final section reviews strategic paths to evaluate risk and manage immunogenicity issues to not only be successful in the clinic but also throughout the entire life cycle of a drug. Case studies will be used throughout the workshop to demonstrate the various theoretical points.
As Senior Director of Biotechnology at Catalent, 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. 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 biopharmaceutical development services including bioanalytical and immunogenicity development solutions, go to www.catalent.com/development.
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing 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 9,000 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.