Downloads
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.