Newsletter | July 2, 2025

07.02.25 -- Ask The Pros — The Latest In Downstream HCP Mitigation

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Webinar: Best Practices For PUPSIT Assembly Design And Operation

This webinar explores the design and implementation of PUPSIT in sterile filtration, covering regulatory expectations, system configurations, equipment layout, and integration into existing processes. It includes practical examples, design challenges, and best practices for integrity testing. Key topics include regulatory guidance, single-use integration, common test devices, and pitfalls to avoid, with a Q&A session for participant-specific concerns. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Ask The Pros — The Latest In Downstream HCP Mitigation

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

Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

A Guide To Scaling Protein Purification

Discover the essentials of scaling protein purification and tackling challenges like purity, cost-efficiency, and scalability. Gain practical strategies and solutions to achieve reproducible, scalable results.

Get Reproducible Purification Scale-Up Results Faster

Is it difficult to reproduce laboratory purification at process scale? We evaluated three prepacked columns from 1.6 to 33 cm column inner diameter (ID) with 20 cm bed height to observe their purification profiles.

Antibody-Drug Conjugates: Manufacturing Precision Medicines

The mAb intermediate is engineered for precise delivery of the linker-payload complex. Discover how rigorous storage measures ensure its quality, which is crucial for successful conjugation and functionality.

DOWNSTREAM MANUFACTURING SOLUTIONS

Protein Capture Devices For Antibody Purification - W.L. Gore & Associates

Minimizing Fluid Loss By Monitoring Back Pressure During Clarification - Avantor

A Gloveless Aseptic Filling System For Vials, Syringes, And Cartridges - Cytiva

FOCUS ON FILL-FINISH

Small Is Powerful And Sustained

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

An Industry-Backed Approach To Container Closure Integrity

Ensuring container closure integrity in an increasingly complex pharmaceutical industry requires a holistic approach that incorporates quality control into all phases of product design and development.

FILL-FINISH SOLUTIONS

MicroCNX Nano Series Connectors Assembly Overview - CPC

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