BioPhorum

ARTICLES BY BIOPHORUM

• Considerations For Viral Clearance In Cell And Gene Therapy

  7/27/2023

  Assuring viral safety in cell and gene therapy (CGT) products poses a unique challenge. This article focuses on adeno-associated viral (AAV) vectors but also applies to other viral vectors where possible.

• A Practical Proposal For Standardizing Traceability Of Cell And Gene Therapies

  7/21/2023

  For personalized therapies, it is imperative that patients are treated with the product meant specifically for them. Mistakes in products or on labels that lead to the wrong therapy being administered to the patient are likely to have fatal consequences. BioPhorum presents a practical vision for standardizing the traceability of cell and gene therapies across the value chain.

• Container Closure Integrity Testing Strategies For Gene Therapies

  6/7/2023

  Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.

• Improving Digital Integration Between Biomanufacturers & Partners

  5/1/2023

  Sponsors are working with more contract organizations, and contract organizations are working with more sponsors. There is often a mismatch in digital maturity (IT capabilities) between the two sides of a partnership. We must work toward a bidirectional sharing of data and process knowledge. This road map from BioPhorum will help.

• 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. 

• Using QbD Principles To Register Innovative Raw Materials

  2/13/2023

  Control of biopharmaceutical raw materials is defined by the license holder. We propose a best practice approach to registering innovative and complex raw materials based on quality by design (QbD) principles. It can be applied to different families of non-compendial raw materials used when manufacturing biologics.

• Release Specifications For Plasmid MCBs, Plasmid DNA

  1/10/2023

  Plasmid release specifications are critical to the manufacture of many cell and gene therapy products, but current guidance defining expectations for the release of plasmids as a starting material is limited. In this article, BioPhorum summarizes key industry feedback, best practices, and member discussions on the topic.

• A Methodology To Support Particle Investigations In Biopharma Products

  11/22/2022

  Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

• A Phased Approach To Adopt In-Line Monitoring & Real-Time Release

  10/26/2022

  The biotech plant of the future will use in-line monitoring (ILM) and real-time release (RTR), which includes process technology, operational systems, facility design, and construction innovations that will increase capacity and enable efficient processes. This article is a guide to adopting that vision.