Newsletter | November 6, 2024

11.06.24 -- Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards

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FOCUS ON DOWNSTREAM MANUFACTURING

Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards

A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

From Bottlenecks To Breakthroughs: Mastering Buffer Management

Watch to explore strategies to overcome buffer-related bottlenecks in large-scale biomanufacturing.

Real-Life Application Of Intensified Chromatography – See The Results

Explore the impact and benefits of multi-column chromatography, taking into consideration product quality consistency as well as the potential cost and resin savings compared to batch chromatography.

Advancing Buffer Management And Single Use Inline Buffer Formulation

In this podcast, you will learn about the criticality of buffer to the biomanufacturing process as well as the challenges inherent to handling the sheer amount that is needed almost continuously.

The Transformative Impact Of Single-Use Centrifuges

Single-use centrifuges have the potential to become the new standard, and meet the need for innovative production methods when facing emerging modalities and next-generation biotherapeutics at scale.

A Brief History Of Wastewater Testing And Pathogen Detection

What if we could use wastewater to identify and address the next infectious disease? Wastewater surveillance is developing as a powerful tool for public health sector and one with history centuries old.

Bridging Anti-E. coli HCP Antibodies and E. coli Antigens

Read this expert comparative coverage analysis study performed to assess the reactivity of anti-E. coli HCP antibodies that support ELISA kits.

Characterization Of A Therapeutic mAb, Antigen-Binding Fragments

Determining size homogeneity of a mAb in solution is important for comparability and characterization. See the results from this study of an IgG1 antibody cleaved into antigen-binding fragments followed by Protein A purification.

Performance Parameters In Protein Purification

Explore the process of protein purification and the five parameters on which you can gauge your success.

Why Single-Use? Single-Use Technology In Pharmaceutical Manufacturing

Learn about the role of single-use technology in advanced therapy manufacturing, why pharmaceutical manufacturers are switching to disposable technology, and more.

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No matter how robust and consistent your assays are today, the time will come when a tech transfer, a scale-up, a supplier change, a partnership deal, or some other force of change requires an analytical methods transfer. You should be preparing for that day. Join Bioprocess Online Live on December 3rd for best practices to ensure the methods you're developing today are seamlessly transferrable tomorrow. Registration is free thanks to the support of BD Bioscience.

DOWNSTREAM MANUFACTURING SOLUTIONS

High Binding Capacity And Rapid Antibody Purification - W.L. Gore & Associates

Secure Connections In Cryogenic Applications - Nordson MEDICAL

Resin Offering High Productivity And Robust Processes - Cytiva

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