Catalent Scientist’s Article Featured by Biotechnology Industry Organization
Released on: April 3, 2009, 6:09 am
Author: Dan Dunlop / Jennings
Research Triangle Park, N.C., April 2, 2009 – 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.
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.
Contact Details: Dan Dunlop, President
104-A North Elliott Road
Chapel Hill, NC 27514