INSIGHTS ON REGULATORY COMPLIANCE

• What Does Annex 1 Mean For Cryovial Filling?

  New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.

• Leveraging A Modern HPLC System For Peptide Drug Substances Analysis

  This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers

  Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.

• Drive Innovation With Validation 4.0

  7/1/2025

  Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.

• A Driving Force For Advanced Cleanroom Standards

  2/18/2025

  Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

• The Impact Of The FDA's New CSA Draft Guideline

  2/24/2025

  Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

• Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want?

  12/5/2023

  In this segment, Combined Therapeutics CSO Thomas Van Cott, Ph.D. and Omega Therapeutics Executive Director, Process Development and Analytical Sciences Jeff Atkinson, Ph.D. address regulators’ likely safety and CQA concerns as well as audience questions regarding variable and changing RNA constructs.

• Overcoming Gene Therapy Cost Roadblocks On The Path To Patients

  7/23/2025

  Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.