Expert Insights On Upstream Bioprocessing

1. Calculating The Right In-House/Outsource Mix For ADC Manufacturing 8/21/2025

   Antibody-drug conjugate innovators often question whether to outsource manufacturing activities or bring them in-house. Here are some key considerations.

2. Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing 8/19/2025

   Continuous perfusion manufacturing came about before the technology was mature enough to support it. Now, new data suggests an inflection point in the status quo.

3. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

   A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

4. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

   Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

5. Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need 6/18/2025

   In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.

6. The Promise And Challenges Of Cell-Free Protein Systems 6/10/2025

   CFPS use cell lysates or purified enzymes to synthesize proteins. They have emerged as a promising alternative to production with living cells.

7. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

8. Is Early Automation The Key To Scalable Cell Therapy Manufacturing? 5/8/2025

   Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.

9. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

   Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

10. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.