Downloads

  1. Particle Loss Studies 12/15/2025

    Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.

  2. Bridging The Gap Between Product Readiness And Equipment Availability 12/15/2025

    Discover how manual precision at scale bridges packaging gaps, accelerates product launches, and ensures uninterrupted supply to deliver quality when automated equipment isn’t yet operational.

  3. Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing 12/15/2025

    How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

  4. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  5. Lentiviral Vector Upstream Process 12/12/2025

    Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.

  6. Hear From The Experts: LNPs Driving The Future Of Cell Therapy 12/12/2025

    Explore how lipid nanoparticles are driving breakthroughs in cell therapy, from mRNA-based immune cell engineering to genome editing for CAR T cells and HSPCs from leading experts.

  7. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

    MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

  8. Right-First-Time Production Via Quality By Design 12/12/2025

    Pharma manufacturing is changing fast. Learn how Process Analytical Technology (PAT) empowers real-time process control, boosts efficiency, and ensures compliance.

  9. Make Your Production Sites Adaptable And More Efficient 12/12/2025

    Pharma faces mounting complexity and tighter margins, demanding agile, future-ready production. Discover how smart manufacturing enables faster adaptation and continuous therapy availability.

  10. Accelerating Manufacturing Digitalization With Low-Code Development 12/12/2025

    Learn how a low-code approach to MES systems delivers speed, flexibility, and compliance, empowering manufacturers to overcome bottlenecks and embrace digital transformation with confidence.