Expert Insights On Downstream Bioprocessing

1. 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.

2. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

   The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

3. Incorporating AI Tools Into Downstream Process Optimization 5/8/2025

   Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.

4. 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.

5. 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.

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. 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.

8. A Closer Look At Buffer Recycling For More Sustainable Bioprocessing 4/8/2025

   Recognizing the unexplored potential to save resources, one researcher realized consumption reduction of up to 50% during a key phase of downstream processing.

9. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

   The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

10. Using Digital Shadows To Reinforce Downstream Modeling 3/26/2025

    This model class transfers real-time information in one direction, and it can help bridge the gap between digital model and fully functioning digital twin.