Newsletter | July 23, 2025

07.23.25 -- Managing Extractables And Leachables In HPAPI Manufacturing

SPONSOR

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.

FOCUS ON FILL-FINISH

Managing Extractables And Leachables In HPAPI Manufacturing

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

5 Advantages Of Dual-Sourcing In Pharmaceutical Fill/Finish

Delve into the specific advantages of dual-sourcing in pharmaceutical fill/finish, exploring how this approach can bolster supply chain resilience, increase capacity, and accelerate commercialization.

A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

FILL-FINISH SOLUTIONS

The NanoAssemblr® Spark™ RNA-Lipid Nanoparticle Formulation - Cytiva

Capacity Update October 2024: Fill/Finish - Alcami

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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 DOWNSTREAM MANUFACTURING

Optimizing Virus Filtration Validation

Explore guidance regarding the effective validation of a virus filtration process in the laboratory, including the fundamentals of viral filtration and an examination of relevant regulatory guidelines.

Challenges, Methods, And Solutions For Obtaining Optimal Starting Material

For treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.

Protein A Membrane Tech To Eliminate Antibody Purification Bottlenecks

New membrane-based, Protein-A affinity chromatography technology streamlines drug development and enables a wider variety of molecules.

DOWNSTREAM MANUFACTURING SOLUTIONS

A Pilot-Scale, Sedimenting Centrifuge - CARR Biosystems

Streamline Your Media Preparation And Column Packing - Asahi Kasei Bioprocess

Pellicon® Capsule With Ultracel® Membrane - MilliporeSigma

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