ARTICLES BY BIOPHORUM

  • 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.

  • 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.

  • 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 Integrate Continued Process Verification & Annual Product Review For Biologics
    1/3/2022

    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. 

  • 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.

BioPhorum