Newsletter | April 29, 2026

04.29.26 -- Process Engineering's Key Role In Sterile Injectable Facility Design

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Aseptic filling trends shaping the future

Learn how modern aseptic filling is evolving as personalized medicines, automation, and Annex 1 expectations reshape operations. With insights from industry veterans Scott Harper and Brent Lieffers, explore isolators, contamination control, real-time environmental monitoring, and data-driven approaches to modernize safely and accelerate time to clinic. Read the full article to stay ahead.

FOCUS ON FILL-FINISH

Process Engineering's Key Role In Sterile Injectable Facility Design

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

Considerations And Options For Prefilled Syringes

Explore the benefits of prefilled syringes to enhance product convenience, reduce drug waste, and streamline your pharmaceutical manufacturing process.

The Evolving Landscape Of Fill/Finish: Trends, Challenges, What's Ahead

Discover how surging demand for GLP-1 and other therapeutics is transforming fill/finish capacity and regulatory standards. Learn how CDMOs are adapting to the complex needs of emerging modalities.

FILL-FINISH SOLUTIONS

An Integrated, Verified PFS System For Vaccines - West Pharmaceutical Services, Inc.

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Webinar: The Shift to High Concentration mAbs: 3 Critical UF/DF Challenges and How to Solve Them

As monoclonal antibodies shift toward high concentration formulations for subcutaneous delivery, UF/DF operations face new challenges. In this Repligen webinar, experts explore how rising viscosity impacts flux, fouling, and aggregation and why legacy TFF approaches fall short. Learn strategies and automated TFF solutions to build scalable UF/DF processes for next generation mAbs. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Utilizing Retrovirus-Like Particles To Evaluate Viral Clearance

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.

Future-Proof Your Bioprocess: The Science And Supply Chain Of Enzymes

High-purity trypsin and carboxypeptidase B enable protein processing in biopharma manufacturing. Learn how animal-free, GMP-grade production meets exacting quality standards for growing operations.

Four Common Pitfalls To Avoid In UF/DF Setup And Scale-Up

See how small UF/DF decisions can create major scale-up challenges, as well as practical ways to improve membrane selection, reduce manual operations, and boost PD–MSAT alignment.

Design, Operation, And Automation In Aseptic Filling Systems

Read about a modular and compact filling and closing system for flexibility in pharmaceutical manufacturing operations and automated processing of vials, syringes, and cartridges.

DOWNSTREAM MANUFACTURING SOLUTIONS

How To Implement Pre-Use Post-Sterilization Integrity Testing (PUPSIT) Without The Pain - Cytiva

Advanced Purification To Improve Your Manufacturing Efficiencies And Timeline To Clinic - Ecolab, Purolite Resins

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