Biosimilar Manufacturing solution center

1. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

   Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

2. 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.

3. 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.

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. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

   Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.

6. Filtration: The Overlooked Enabler Of Process Intensification 7/20/2026

   Process intensification depends on more than facility changes. Smarter choices can help improve yield, throughput, and sustainability, turning an often-overlooked step into a meaningful contributor.

7. Process Intensification And Other Ways To Adapt To Changing Needs 7/20/2026

   As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.

8. 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.

9. 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.

10. 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.