The purpose of this BioPhorum member only survey is to assess the use and control strategy for ready to use (RtU) cells used in bioassays.
Viewing related articles
This benchmarking survey from the BioPhorum Forced Degradation team has conduced a benchmarking survey for formal comparability assessments.
This member only survey covers the challenges of working with ultra-high concentration formulations, including; low dose volume products, viscosity aspects related to manufacturing and delivery, manufacturing and filling, automated screening, analytical challenges, osmolality considerations (hyper and hypo), syringeability, acceptable injection forces.
A BioPhorum member resource which captures journal or paper articles that BioPhorum members have successfully used in their clinical and license applications. The database captures: Process Stage Purpose Reference - submission section Paper Reference Comments The tool is available for members to use and the Phorum is encouraging their workstreams to add to it. DG hopes to see this list grow and become a useful resource to...
A comprehensive benchmarking survey aimed at collating data on the technical practices involved in therapeutic protein production and evaluation of if/how this has changed in response to the COVID-19 pandemic.
A BioPhorum member only survey gathering feedback on initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.) and the outcome of health authority review and approval of the submission.
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.