PRLog (Press Release) – Oct 28, 2010 – Research Triangle Park, NC – Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be leading a pre-conference workshop entitled “Fit for Purpose Bioassay Development & Validation” at the 9th Annual Biological Assays Conference in London on November 2, 2010. The conference is designed to improve the development, validation and analysis of biological assays by exposing biopharmaceutical professionals to detailed case studies from fellow peers.
Potency bioassays are an integral part of release testing and stability studies for biotechnological products. However, there is a lack of clarity of how much work is required at each development phase to maintain scientific rigor and meet regulatory expectations. Dr. Menendez’s workshop provides a logical plan to progress the potency bioassay from a tool to assist in pre-clinical process evaluation throughout final commercial implementation. The workshop provides strategies to comply with current regulatory guidance and discusses options to determine acceptance parameters not only for the method but also for each sample. Participants in this workshop will learn a common sense chronological pathway that can easily be adapted for any biopharmaceutical method. For more information about the conference and Dr. Menendez’s pre-conference workshop, go to http://www.informaglobalevents.com/event/bioassays/highl ....
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. Dr. Menendez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.
To download a copy of Dr. Menendez’ presentation after the conference, go to http://www.catalent.com.
For more information on Catalent’s broad range of biopharmaceutical development services including bioanalytical and immunogenicity development solutions, go to http://www.catalent.com/development.
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 9,000 people at 29 facilities worldwide and in fiscal 2010 generated more than $1.7 billion in annual revenue. For more information, visit http://www.catalent.com.
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 9,000 people at 29 facilities worldwide and in fiscal 2010 generated more than $1.7 billion in annual revenue. For more information, visit http://www.catalent.com.
