ARTICLES BY BIOPHORUM
Improving Digital Integration Between Biomanufacturers & Partners5/1/2023
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 & Systems4/20/2023
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 Fingerprinting3/13/2023
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 Materials2/13/2023
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.
A Methodology To Support Particle Investigations In Biopharma Products11/22/2022
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 Release10/26/2022
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 Considerations9/12/2022
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 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 Integrate Continued Process Verification & Annual Product Review 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.
New Plug-And-Play Guidances: 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.
Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance8/27/2021
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.