Insights On Pharmaceutical Production

  1. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

  2. A Modular, Fully Automated Aseptic Processing Solution 5/12/2026

    Automated, no-touch aseptic processing enhances batch integrity and throughput. Explore how modular robotics and recipe-driven filling adapt to the complex demands of modern drug development.

  3. The Importance Of Flexibility In HPAPI Small-Batch Manufacturing 1/27/2025

    Watch as experts provide insight into the challenges of HPAPI manufacturing and offer proven strategies for achieving the flexibility required for small-batch production.

  4. How A Global Pharma Manufacturer Reduced Line Stops And Increased OEE 10/24/2024

    Gain insight into how a leading pharmaceutical company identified the root cause of long-standing inefficiencies, optimized performance, and productivity with unprecedented speed and accuracy.

  5. Oligonucleotide Synthesis: Scale-Up Made Simple 10/16/2024

    Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

  6. A Collaboration With Fresenius Kabi BioPharm 5/19/2025

    Explore how biosimilar development is advancing through collaboration, innovative cell culture strategies, and the use of advanced media to meet biomanufacturing goals.

  7. Epigenetics Application Guide: RNA Modifications 9/26/2024

    Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.

  8. Scaling Up Your E. Coli pDNA Process From Parameter Screening To Pilot Scale 6/26/2025

    Discover a systematic approach to scalable plasmid DNA production using E. coli OneShot Top10, which features DOE-driven optimization and key insights for efficient biomanufacturing success.

  9. HILIC Method Migration Part 2: Troubleshooting Peak Splitting Of Cetirizine 9/18/2024

    The system suitability solution sample from the cetirizine hydrochloride organic impurities USP monograph was used to assess the impact of the needle wash and needle wash design on HILIC separations.

  10. The Evolution Of Parenteral Manufacturing For Sensitive Drugs 3/23/2026

    Parenteral manufacturing is advancing with better facilities, single‑use systems, continuous processing, and Annex 1 compliance to meet demand for specialised biologics and personalised therapies.