Phase-Appropriate Validation Of Bioassays To Be Presented By Catalent At WCBBA Workshop
SOMERSET, N.J. – October 15, 2018 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that one of its scientific experts will host a workshop during KNect365 Life Sciences’ annual Well Characterized Biologics & Biological Assays conference (WCBBA) at the Hilton Washington DC / Rockville Hotel & Executive Meeting Center, Rockville, Maryland on Oct. 24 – 26, 2018.
The pre-conference workshop, titled “Taking it to Another Level: Phase-Appropriate Validation of Bioassays” will be hosted by Mike Sadick, Ph.D., Principal Scientist, Catalent Biologics, on Wednesday, Oct. 24 at 9:00 a.m. Understanding phase-appropriate validation is critical because it has the potential to reduce cost and timelines associated with biologic drug development. The workshop will aim to help attendees:
- understand what phase-appropriate validation is, how it applies to bioassays, and how it differs from qualification;
- understand the similarities and differences between ICH guidelines and USP guidelines;
- improve the success rate of their validation programs by ensuring pre-validation activities are implemented.
Dr. Sadick coordinates and oversees bioassay, ELISA and molecular biology projects for Catalent Biologics. Previously, he managed the company’s bioassay/relative potency team for 10 years at Catalent Biologics’ facility in Kansas City, Missouri. Prior to that, Dr. Sadick worked at Eli Lilly and Co. as a Research Advisor leading its bioassay groups, molecular biology and virology in support of Phase 1-3 projects, as well as providing guidance for commercial bioassay testing. Before his tenure at Eli Lilly, he ran bioassay groups at Genentech in San Francisco. Dr. Sadick has an extensive background in cellular biology, cellular immunology and receptor signaling, molecular biology and biochemistry. He received his master’s degree and doctorate in immunology from University of Washington in Seattle, and his bachelor’s degree in biology from Johns Hopkins University in Baltimore, Maryland.
For more information visit the workshop landing page.
To arrange a meeting with any of the attending Catalent executives at the event, contact Richard Kerns at NEPR – richard@nepr.eu
Media Contacts:
Chris Halling
+44 (0)7580 041073
chris.halling@catalent.com
Richard Kerns
+44 (0) 161 728 5880
richard@nepr.eu
ABOUT CATALENT BIOLOGICS
BiologicsCatalent Biologics provides advanced technologies and tailored solutions for biologic and biosimilar development, from DNA to commercial supply, through our extensive Biologics network including: Madison, Wisconsin; Emeryville, California; Kansas City, Missouri; Morrisville, North Carolina and Bloomington, Indiana. For more information on Catalent Biologics, visit Biologics.Catalent.com
ABOUT CATALENT
Catalent, Inc. (NYSE: CTLT), is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated over $2 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.