ARTICLES BY BIOPHORUM

• 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.

• 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.