Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals

Best practices in bioassay development to support registration of biopharmaceuticals has been written by members of BioPhorum Development Group Bioassay workstream and published online in BioTechniques.

“An original and highly relevant paper, which the authors believe will have significant impact on harmonizing biopharmaceutical development practices and allow scientists and regulators to view current thinking in this area,” said lead author of the paper, John R. White, Director, Biopharm Analytical Sciences, Biopharm R&D at GSK. He identifies the key strength of this paper as “the open cross-company collaboration and sharing of information, which has, for the first time, led to a very practical industry-wide approach to the best practices for developing, implementing and maintaining cell-based assays.”

This was also echoed by Ned Mozier, Vice-President, Portfolio and Project Management at Pfizer who agreed, “I think this is a really helpful paper in that it’s a current reflection of the practices of some of the major biologics companies.  I don’t think there has been anything quite like it before.”

In writing the collective paper, members of the workstream reflected on how bioassays are developed, challenged current thinking and discussed the benefits of different practices, unearthing areas where members agreed – and those where they did not.

Gael Debauve, Head of the Bioassay Development Group at UCB felt that the paper is “a wonderful benchmark for us to see where we are and what steps still need to be taken; as well as identifying how we can learn from the good practices identified.”

Click here to find a 'Members Only' companion presentation presented at USP's 8th Bioassay workshop and at the PEGS Summit program at BioProcess International. Boston MA, Sept 2020