GUEST COLUMNISTS

• Are Biopharma Companies Outsourcing Their Ability To Think?

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

• Why Operational Readiness Is The Missing Piece In Biosimilar Adoption

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

• Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring

  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.

• Exploring Takeda's Template For Sustainable Steam Generation

  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.

• Transforming Computer System Validation In The Life Sciences Industry

  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.

• Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

  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.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

  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.