Newsletter | August 14, 2024

08.14.24 -- Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD

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Overcoming Bispecific Antibody Purification Challenges

The purification of bispecific antibodies (bsAbs) can be challenging due to the aggregation and chromatographic approaches. Process chromatography scientists compared CHT Ceramic Hydroxyapatite Media to traditional cation exchange (CEX) resins for bsAb workflows. Over 97% purity, low levels of high molecular weight impurities (HMW), and an eightfold decrease chromatography-induced aggregation were achieved with CHT compared to CEX-based resins. View the full article.

FOCUS ON DOWNSTREAM MANUFACTURING

Bacterial Endotoxin Testing: Calculating Endotoxin Limits & MVD

The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

The Heroes Of Vaccine Development: Lipid Nanoparticles

Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.

Vial Breakage During Lyophilization: Root Causes And Mitigation

Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

Overcoming Formulation Challenges For mRNA, High-Concentration Proteins

Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

Revolutionizing Particle Characterization With Image Analysis And ML

The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.

Achieving Protein A Purification Using DurA Cycle A50

This protein A resin, developed for purifying various mAbs, ensures consistent agarose beads with a uniform particle size distribution. Explore the resin's recommended conditions and parameters.

Developing A Large-Scale Tangential Flow Filtration Process

Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

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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.

DOWNSTREAM MANUFACTURING SOLUTIONS

A Single-Use Chromatography System For Small Volumes - Cytiva

Sterile Filtration Solutions For Single-Use Bioprocessing Systems - Entegris, Inc.

Delivering Top Quality Fill Finish Manufacturing - Ajinomoto Bio-Pharma Services

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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.

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