Expert Insights On Upstream Bioprocessing

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Emerging Trends In mAbs Manufacturing In 2025 And Beyond 2/11/2025

   Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

7. Using Simple Spreadsheet DoE To Optimize The Protein Pipeline 1/21/2025

   Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

8. Host Cell DNA Impurities: A Unique Challenge For rAAV 1/10/2025

   The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.

9. Hear Me Out — Cell Therapy GMP Starts With The Donor 1/9/2025

   Regulators also have indicated they expect allogeneic cell therapy donors to meet more rigid eligibility requirements and undergo screening.

10. A Justification For Using In-Process Controls In Place Of Cleaning Validation 1/9/2025

    This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.