ARTICLES BY BIOPHORUM
Biopharma Facility Modular Design & Construction: Key Considerations9/12/2022
In terms of 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 that standardized modules and components reach, the wider the benefits to the entire industry.
Qualifying Working Cell Bank Replenishment9/6/2022
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 Supply8/16/2022
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 Therapies6/10/2022
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.
Overcome Potency Assay Development Challenges In Gene Therapies4/22/2022
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 Challenges1/21/2022
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.
How To Integrate CPV & APR For Biologics1/3/2022
In biologics manufacturing, continued process verification (CPV) requirements are similar to those for evaluating quality standards that determine changes to manufacturing or control procedures in an annual product review (APR). Many companies have mirrored CPV and APR reporting processes. Few have realized the efficiencies of integrating them.
Solving The 4 Serialization Challenges Of Track & Trace11/17/2021
More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.
How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins11/3/2021
Host cell proteins are process‐related impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.
Computerized Systems Validation And Audit Trail Requirements10/18/2021
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.