ARTICLES BY BIOPHORUM

• 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. 

• 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.

• Biopharma Facility Modular Design & Construction: Key Considerations

  9/12/2022

  In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.

• Qualifying Replenishment Working Cell Banks

  9/6/2022

  Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. The availability of well-characterized cell banks is imperative to ensure drug product supply. This article shares regulatory tips for cell bank registration and regulatory considerations when replenishing a working cell bank.

• The Process Map To Ensure Biopharma Raw Materials Supply

  8/16/2022

  In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

• How To Test Master Cell Banks As A Starting Material For Gene Therapies

  6/10/2022

  BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.

• 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.

• Proposed Solutions For Cell & Gene Therapy Validation Challenges

  1/21/2022

  As more experience and knowledge are gained on cell and gene therapy manufacturing processes, some challenges will be resolved and others will be identified. This article delves into challenges and proposed solutions for manufacturing process validation, designing PPQs for autologous cell therapy, and analytical method validation.

• 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.

• Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance

  8/27/2021

  Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.