Biosimilar Regulatory 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. 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.

3. 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.

4. 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.

5. A Scalable Analytical Method For Quality-Driven AAV Characterization 7/1/2026

   AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.

6. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools 6/30/2026

   Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

7. FDA Explains How To Respond To Form 483 Observations In New Draft Guidance 6/29/2026

   In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.

8. What Biopharma Often Overlooks In A Scheduled Shutdown 6/26/2026

   Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

9. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures 6/23/2026

   A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

10. Is Your AI Model Trustworthy And Credible In GMP Processes? 6/17/2026

    Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.