By Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com
The 20th annual Well Characterized Biopharmaceuticals (WBCP) meeting will take place in Washington, D.C. the week of January 24th. I attended the inaugural meeting and have only missed one in the last 20 years. This is always an excellent meeting covering both the scientific and regulatory aspects of biopharmaceutical development in equal measure. I am particularly excited about this year’s topics including Higher Order Structure, Combo Products, Biosimilars and Pre-clinical development. I am looking forward to seeing you at the ABC Labs booth to discuss some of our exciting studies. These include:
- · Utilizing the WES system to quantitate both intact and degraded protein DP in fecal matter
- · Supported two successful IND submissions for Antibody Drug Conjugates in 2015 with a third in progress. This included full characterization, method development, qualification, release and stability studies. These submissions had NO comments regarding the chemistry section of CMC.
- · Supported our clients during difficult times
- During a Phase II trial, reagent changes caused bioanalytical ELISA results to be “offset” from the previous results. We were able to troubleshoot and solve the client’s problem.
- When a client suddenly severed a relationship with its CRO we were able to transfer, qualify and release methods in support of GMP DS and DP while meeting deadlines.
We hope to speak to you about your biopharmaceutical analytical needs during the breaks, as well as at the Exhibitor Reception, Wednesday, from 5:30-7:00 PM.
