Downloads

1. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

   Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

2. Achieving Greater Downstream Recovery By Minimizing Upstream Loss 7/18/2025

   A novel cell lysis solution can improve rAAV recovery by rapidly rupturing cell membranes while remaining compatible with existing workflows. Discover a scalable and efficient lysis alternative.

3. Keep Your Upstream Flowing: Global Strategies for Resilience and Redundancy 7/17/2025

   Ensure your cell culture media supply remains uninterrupted. Explore proactive strategies for global manufacturing equivalency and consistent media delivery.

4. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

   The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

5. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

   Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

6. Demonstrating A Modular Selectivity With A Weak AEX-HIC Resin For Achieving High mAb Purity And Recovery In A Downstream Process 7/16/2025

   Learn how a scalable multimodal resin with adjustable selectivity was employed to design an efficient mAb purification process in a flow-through mode.

7. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

   Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

8. Tackling Residual DNA Testing In Biotherapy Manufacturing 7/16/2025

   Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

9. Unlocking Digital Transformation: Embrace CSA For Rapid Innovation 7/16/2025

   Gain valuable insights from industry leaders on how life sciences manufacturers can embrace innovation and digital transformation through the FDA’s CSA guidance.

10. Storage Solutions For Cryogenic Applications 7/16/2025

    Discover a product that is engineered for bioprocessing to support storage, processing, filling, and transport in closed systems that also ensure contamination control and meet REACH and RoHS standards.