Newsletter | July 16, 2025

07.16.25 -- Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

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Process: Intensified. Drug Manufacturing: Accelerated

It’s never been more important to intensify — and with expert insight, cutting-edge solutions, and maximized value, it’s never been easier. Fast-forward your success with solutions that reduce complexity, cut time to market, and unlock greater potential at every step. Learn more here.

FOCUS ON DOWNSTREAM MANUFACTURING

Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

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.

Utilizing RVLP To Evaluate Viral Clearance For Multiple Modes Of Separation

This study demonstrates that Retrovirus-like particles (RVLPs) can be used to accurately assess viral clearance, providing a valuable tool for the development of biopharmaceutical manufacturing processes.

Key Financial Considerations For Clinical Injectable Drug Manufacturing

This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

Solving Bispecific Antibody Heavy-Light Chain Mispairing

Explore how the bYlok® bispecific pairing technology can be used to solve heavy-light chain mispairing in bispecific antibodies and how it compares with alternative scaffolds.

DOWNSTREAM MANUFACTURING SOLUTIONS

Making Success More Certain - Bora Pharmaceuticals

Looking For A More Affordable Source Of Protein A Resin? - Thermo Fisher Scientific

Advanced Purification For Efficient Manufacturing, Time To Clinic - Ecolab, Purolite Resins

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Webinar: Achieving High Purity in Complex Antibody Formats

As antibody formats grow more complex, traditional purification methods fall short. This webinar explores tailored strategies for purifying multispecifics and other advanced antibodies. Learn how CaptureSelect™ affinity matrices and orthogonal chromatography tools can streamline workflows, improve selectivity, and boost yield and purity. Real-world case studies offer insights for optimizing processes from development through manufacturing, ensuring robust, scalable outcomes. Click here to learn more.

FOCUS ON FILL-FINISH

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

nanoDSF As An Efficient, High-Throughput Method For ID Testing

Unlock efficient, high-throughput biologics ID testing with a label-free method that analyzes protein stability via thermal unfolding, creating unique fingerprints for rapid quality control.

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Webinar: Process Intensification Strategies: Your Guide to "Doing More with Less"

Unlock the full potential of process intensification in biomanufacturing with Cytiva’s expert-led webinar. Discover how to overcome scale-up challenges and regulatory hurdles while maximizing efficiency, quality, and speed—especially during the critical Phase 2 to commercial transition. Learn cutting-edge strategies like high-seed fed-batch and continuous capture. Don’t miss this chance to future-proof your manufacturing process. Register now! Click here to learn more.

FILL-FINISH SOLUTIONS

Delivering Best-In-Class Nanoparticles - DIANT Pharma

Capacity Update January 2025: Fill/Finish - Lonza

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