Insights On Regulatory Compliance

  1. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

    Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

  2. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

    When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

  3. Development Of A Non-Standard Protein Therapeutic 2/4/2026

    Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

  4. Mitigating Nitrosamine Risks In Pharmaceuticals 6/25/2024

    Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

  5. Simplify Cell Line Development 10/1/2025

    Explore a streamlined method for isolating viable single cells using microfluidic dispensing and whole-well imaging that is designed to improve clonality, cell health, and reproducibility.

  6. Monitoring Compressed Gases For Microbial And Particle Contamination 2/26/2025

    There are several factors associated with active environmental microbial monitoring. Watch to learn how the EU GMP Annex 1 compliance focuses on microbial monitoring in cleanrooms.

  7. Rheology Is An Accurate Predictor Of Pharmaceutical Lotion Stability 5/6/2026

    Rheological creep testing provides a rapid way to predict pharmaceutical lotion stability by linking steady-state viscosity to particle settling behavior, enabling reliable shelf-life estimates.

  8. Automated Validation And Centralized Data 7/23/2025

    Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.

  9. End-To-End Workflow Integration For Antibody Development 1/29/2026

    Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.

  10. Closed Sampling: Crucial For Aseptic Processing 6/26/2025

    Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.