Thursday, December 10, 2020 Daily Archives

Case Study for a Facility-Fit Driven Process Development

by

Time to clinic and time to market are the key drivers for client success in the biopharmaceutical industry. Facility fit is becoming key to understanding process constraints and which aspects of the process have the largest impact on enabling facility fit. Process development with facility-fit constraints in mind will ensure a smooth technology transfer and shorten the timeline of current good manufacturing practice (CGMP) product delivery to clients. Fill out the form below to read this Special Report and learn…

December 10, 2020

BMS hit by FDA 483 with 6 observations at Washington CAR-T plant

by

The Form 483 is a further blow to the potential approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel, made at the Bothell, Washington facility. The form comes after the US Food and Drug Administration (FDA) visited the facility between October 7 and 16 and lists six heavily redacted observations made about manufacturing processes. These include failures in reviewing any unexplained discrepancies and questions around the reliability of Certificates of Analysis (COAs) from third-party vendors; problems with written records of investigations…

December 10, 2020

Boehringer urges FDA to correct ‘strength’ definition for biosimilars

by

Boehringer Ingelheim has filed a Citizen Petition to the US FDA to change its interpretation of how the strength of a biosimilar is determined. Boehringer Ingelheim filed the petition to the US Food and Drug Administration (FDA) last week to change the interpretation of the word ‘strength’ to mean total drug content. Currently, the FDA’s interpretation is based on both the total content of drug substance and the concentration of drug substance. In its Citizen Petition, Boehringer claims that this…

December 10, 2020