Expert Insights On Fill/Finish

1. A Practical Look At Modern Downstream Processing For Biologics 2/25/2026

   Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.

2. Process Engineering's Key Role In Sterile Injectable Facility Design 2/24/2026

   Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

3. A Novel In Vitro Glycosylation Approach For Difficult PTMs 2/19/2026

   Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

4. A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset 2/18/2026

   Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

5. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

   Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

6. Four Reasons You Should Choose Lyophilization for Your Next Project 12/10/2025

   Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.

7. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

   Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

8. 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.

9. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

   These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

10. 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.