ARTICLES BY BIOPHORUM

• A Practical Guide To Defining Priority Data In MES

  3/17/2025

  Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.

• Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data

  1/23/2025

  The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

• A Justification For Using In-Process Controls In Place Of Cleaning Validation

  1/9/2025

  This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

• A Holistic Approach To Container Closure Integrity

  5/20/2024

  Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

• How To Unlock Efficiency In MES Integrations

  5/16/2024

  This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.

• Improving Digital Integration Between Biomanufacturers & Partners

  5/1/2023

  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 & Systems

  4/20/2023

  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.

• 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.

• Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry

  11/17/2021

  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 Proteins

  11/3/2021

  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.

• 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.