ARTICLES BY BIOPHORUM

• Import Product Specifications And Drug Registration Testing For China

  10/6/2025

  This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

• Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities

  8/1/2025

  In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

• A Road Map For PAT Monitoring And Control

  5/8/2025

  Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

• 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.