Expert Insights On Upstream Bioprocessing

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Common Manufacturing Challenges For LBP Formulations 4/23/2025

   As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

7. How CAR-NKs Offer Powerful Therapeutic Flexibility 4/15/2025

   Induced pluripotent stem cells have emerged as a promising platform for producing CAR-engineered NK cells in a standardized, renewable, and scalable way.

8. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

   The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.

9. 4 Key Solid Tumor Therapy Objectives iPSCs Can Help Achieve 4/4/2025

   Induced pluripotent stem cells offer some key biologic, technical, and financial advantages over more established PBMC-derived therapies.

10. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

    The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.