Expert Insights On Cell Line Development

1. Why You Need A Raw Material Control Strategy 4/17/2025

   You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

2. 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.

3. 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.

4. New Reference Standards To Support Quality of AAV Raw And Starting Materials 1/31/2025

   The United States Pharmacopeia aims to help gene therapy manufacturers address the challenges that come with complex starting materials like endonuclease and plasmids.

5. 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.

6. 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.

7. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

   Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

8. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

   This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

9. Cell Culture Trends To Watch In 2025 12/12/2024

   Three upstream processing experts weigh in on advancements from the past year and what they're looking forward to in the year ahead.

10. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

    Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.