Expert Insights On Downstream 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. 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.

3. Ask The Pros — The Latest In Downstream HCP Mitigation 6/20/2025

   Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.