Senior Director of Biotechnology at Catalent To Present Course on Bioassays
on: November 11, 2009, 12:57 am
Jennings and Co.
Ana T. Menendez, Ph.D., Senior Director of Biotechnology at
Catalent Pharma Solutions, will be leading a course in Bioassay Method
Development and Validation. The course is being offered through IBC
Life Science on November 12-13, 2009 in Boston, MA.
Menendez will present a lecture outlining sensible approaches to developing
reproducible bioassays using live systems and/or biologically derived reagents.
Additionally, Menendez will conduct a workshop on writing validation protocols, and
will give participants hands-on experience and case studies, which will add
relevance to lecture material as well as create a point of discussion. Targeted
audiences are bio-analytical scientists, validation specialists, project management
leaders and bioassay scientists involved in bioassay execution. Upon completion of
the course, participants will receive a certificate of attendance.
Bioassays are necessary components of the biopharmaceutical development process as
functional potency assays during release, stability and formulation studies. The
course expands on the importance of the appropriate use of non-analytical techniques
that are critical during PK/PD evaluation and measurement of systematic responses to
drugs, such as immunogenicity. Also included are immunological and enzymatic methods
that are widely used in the detection of biological impurities due to their
increased sensitivity and specificity over analytical methods.
As part of Catalent’s Development and Clinical Services segment, 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.
For more information on Catalent’s broad range of drug and biologic development
services, go to www.catalent.com/development.
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 30 facilities worldwide
and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more
information, visit www.catalent.com.
Contact Details: Dan Dunlop, Jennings
Peggy Albertson, Jennings