Latent Risks to Regulatory Registration & Commercial Release
For any organization developing a biologic, analytical variability and bias are significant risk factors that can sink the Chemistry, Manufacturing and Control (CMC) Package for regulatory registration and commercial release. It is as important as ever to correlate the upstream, downstream and formulation process parameters that define a biologic's 'Critical Quality Attributes' with the specifications for final lot release and product stability. Moreover, the analytical data defining process development, process scale-up, lot release and stability are critical for successful regulatory registration.
For a company that outsources some (or all) of its biologic CMC work, a few key considerations could have a significant impact on its program:
• Is it possible to link the analytical data throughout the lifecycle from pre-clinical to post-launch, thereby minimizing the risk and instances of delays or the need to repeat a study?
• With multiple providers, will variability and analytical bias arising from poor (or non-existent) inter-laboratory control create a regulatory concern at the time of registration or release?
These questions, while rhetorical to some, reveal an important but often overlooked tenet of biologic development. Without tight control of the analytical assays that characterize the process and the product throughout the molecule's lifecycle, a nonsensical dataset might reveal itself at the time of regulatory filing and require time and resources to correct.
Presented by
Raymond Kaiser, PhD,
Vice President, Global Biopharmaceutical CMC Solutions
Dr. Kaiser is an expert in the research, development, QA/QC and technical support of biologic and vaccine products. He has spent 23 years in the biopharmaceutical industry (Lilly, Wyeth/Pfizer, Merck) working on various aspects of the development and manufacture/characterization of biologics, including biosimilars. Dr. Kaiser is expert in Quality by Design, Six Sigma and Total Quality Management. In his current position at Covance, Dr. Kaiser has global responsibility for both large and small molecule CMC solutions.
