Guest Columns

  1. In Bioprocessing, Trusted Data Is A Process Variable 8/6/2026

    As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

  2. Are Biopharma Companies Outsourcing Their Ability To Think? 8/5/2026

    Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

  3. Why Operational Readiness Is The Missing Piece In Biosimilar Adoption 8/3/2026

    Biosimilar success depends on seamless execution. Strong care coordination, patient education, and operational readiness are essential to improve access, adherence, and outcomes.

  4. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

    Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

  5. Exploring Takeda's Template For Sustainable Steam Generation 7/17/2026

    Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.

  6. Transforming Computer System Validation In The Life Sciences Industry 7/10/2026

    Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

  7. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  8. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program 7/7/2026

    In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

  9. An Open-Source Modeling Tool For Suspended Continuous Lyophilization 7/7/2026

    Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.

  10. Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines 6/30/2026

    Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.