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.
Implementation of ready to use cells survey
read more
Benchmarking
Viewing related articles
Use of forced degradation for formal comparability assessments survey
This benchmarking survey from the BioPhorum Forced Degradation team has conduced a benchmarking survey for formal comparability assessments.
Ultra high concentration formulation
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.
Referencing licence applications
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...
Speed to clinic benchmarking survey final report
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.
Product stewardship survey
A BioPhorum member survey looking at the importance of product stewardship that will help form the program for BioPhorum Sustainability. The results of this survey are only available to members of BioPhorum Sustainability.
Clinically relevant specifications setting benchmarking survey
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.
Minimize impact of testing: Sterility and bioburden supplementary survey
A BioPhorum member survey looking at sterility and bioburden testing during batch manufacture/release testing of gene therapy products within BioPhorum C> member companies. The results are available to members of BioPhorum C>.
High Level Analytics workstream rcAAV testing strategies survey
A member only survey to benchmark industry experience with replication competent AAV testing. The outcome of the survey will help stimulate further discussion of the topic within the workstream.
Viral clearance studies prior to Phase I/II and inclusion in IND submissions for AAV product survey
A BioPhorum member only survey to understand how companies are performing viral clearance studies prior to Phase I/II and if members are including these studies within IND submissions for AAV products.