Biosimilar Regulatory solution center

1. 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.

2. 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.

3. 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.

4. 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.

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 FDA Explains How To Respond To Form 483 Observations In New Draft Guidance 6/29/2026

   In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry.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

6. 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.

7. 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.

8. 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.

9. Unlocking The Full Potential Of Antibody-Drug Conjugates (ADCs) 6/15/2026

   ADCs are evolving rapidly. Gain insight into how success now hinges on managing complexity, delivery, and scalability to turn promising designs into viable therapeutic products.

10. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.