Newsletter | August 28, 2024

08.28.24 -- Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations

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Webinar: Novel Chromatography for Antibody Variants and Recombinant Proteins

Developing purification protocols for molecules like bispecific antibodies, antibody fragments, and recombinant proteins might pose challenges. Join Cytiva on September 5th as they discuss strategies for streamlining purification processes using MabSelect™ VH3 resin for bispecific antibodies and Cytiva™ Protein Select™ resin for recombinant proteins. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations

ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

How Your Stainless-Steel Column Is Like A French Press

Understanding how purification columns help operators to better conceptualize the process enables greater understanding and troubleshooting.

Considerations For High Productivity Membrane Affinity Chromatography

Examine results from a study aiming to identify hydrodynamic shear rate, cumulative shear stress, and Reynolds number values likely in high-productivity affinity membrane chromatography.

The Increasing Demand For Sterile Filtration Of High Concentration Drugs

Explore the current trends and challenges with manufacturing high-concentration drug products and an approach to performing extensive filterability trials without a high quantity of expensive product.

AAV Purification Using AEX And Mixed-Mode Chromatography

Recombinant adeno‐associated viruses (rAAVs) are among the most promising vectors for long‐term gene transduction. In this study, chromatography workflow solutions to purify rAAV8 are explored.

Future-Proof Your Aseptic Filling

Using the Cytiva SA25 Aseptic Filling Workcell, a standardized system designed with flexibility built in, ensures that companies can pivot between products quickly and adapt as manufacturing needs change.

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Webinar: Enabling Continuous Processing with Inline Buffer Formulation Systems

Join us on September 18th as we address obstacles faced during the transition to continuous processing, such as integration, real-time monitoring, and regulatory compliance. Learn practical solutions and technological advancements that can mitigate these issues, ensuring a smooth and effective implementation. We will highlight how inline buffer formulation supports seamless continuous production and how to leverage this technology to optimize your biopharmaceutical manufacturing processes.

DOWNSTREAM MANUFACTURING SOLUTIONS

Valved Quick Connect Couplings - Nordson MEDICAL

Robust And Reliable Connectors With A 1½ Inch Flow Path - CPC

An Automated Plasmid Purification Solution - Thermo Fisher Scientific

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AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.

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