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A BioPhorum member only benchmarking survey looking at the converting the implementation of PAT for Raman and flow VPE technologies
A BioPhorum member only benchmarking survey looking at the similarities and differences between strategies of member companies on the qualification and validation of bioassays.
The outcomes of several discussions on a survey conducted on forced degradation studies oxidation studies is available in this BioPhorum member only document.
A benchmarking survey looking at the Forced Degradation Study (FDS) correlation to long term degradation. It demonstrates the challenges in the area experienced by member companies.
Forced degradation studies for drug product (DP) (lyo change to liquid for late phase) to support comparability
A BioPhorum member only benchmarking survey looking at approaches on the use of forced degradation studies for drug product (lyo to liquid formulation swap).
Key messages emerging following analysis of the survey are that bridging approaches differ between companies and there is lack of a harmonized approach outside a commercial setting. The Workstream are examining if a guidance paper would be beneficial.
A deep dive into polysorbates and their degradation pathways, analytical methods and the polysorbate control strategy.
Event report for BPDG32. The purpose of the meeting was too share learning on process analytical technologies and their application in process monitoring and control.
Event report for BPDG31, focusing mainly on host cell proteins with the objective of improving participant understanding the challenges, strategies and learnings companies have encountered and developed.
Event report of the 30th BioPhorum Development Group, bringing together 156 participants from 30 companies.