ARTICLES BY BIOPHORUM

• How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield

  8/27/2024

  This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

• Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems

  4/20/2023

  While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

• Best Practices For Cell Culture Media Fingerprinting

  3/13/2023

  This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available. 

• How To Overcome Potency Assay Development Challenges For Gene Therapies

  4/22/2022

  In gene therapy development and manufacturing, developing and validating appropriate potency assays that reflect the mechanism of action acceptable to regulators is a process fraught with challenges. The FDA advocates the use of a matrix approach, and this article shares best practices of this approach.

• New Plug-And-Play Guidances: Computerized Systems Validation And Audit Trail Requirements

  10/18/2021

  A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption  challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.