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.
Benchmarking
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Use of forced degradation for formal comparability assessments survey
May 2022 | Benchmarking, Deliverable, Deliverables Report, Development Group, Forced Degradation Studies
This benchmarking survey from the BioPhorum Forced Degradation team has conduced a benchmarking survey for formal comparability assessments.
Ultra high concentration formulation
May 2022 | Benchmarking, Deliverable, Deliverables Report, Development Group, Formulation and Drug Product Development
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
Apr 2022 | Benchmarking, Deliverable, Deliverables Report, Development Group
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
Apr 2022 | Accelerate CMC Development to Marketing Application, Benchmarking, COVID 19, Deliverable, Deliverables Report, Development Group
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
Mar 2022 | Benchmarking, Deliverable, Deliverables Report, Sustainability
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
Mar 2022 | Accelerate CMC Development to Marketing Application, Benchmarking, CMC Regulatory, Deliverable, Deliverables Report, Development Group
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
Feb 2022 | Benchmarking, Cell & Gene Therapy, Commercialization, Deliverable, Deliverables Report
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
Jan 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, High Level Analytics
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
Oct 2021 | Benchmarking, Cell & Gene Therapy, Deliverables Report, Validation
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.