Newsletter | August 7, 2024

08.07.24 -- Bacterial Endotoxin Testing: Prerequisites & Reagent Preparation

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Webinar: Building an Effective Contamination Control Strategy for Sterile Filtration

It is important that end-users understand what factors to consider when executing a CCS for sterile filtration and the types of risk assessments that should be conducted. Join us on August 13th with Cytiva as we discuss filter selection, integrity testing, filter validation and considerations for performing pre-use post sterilization integrity testing (PUPSIT). Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation

In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

Constraints And Solutions For Biopharmaceutical Manufacturing

Dissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each.

The Process Of Developing Monoclonal Antibodies For Clinical Use

Explore the potential of mAbs in treating diverse conditions, from cancer to infectious diseases, and learn about their transformation from scientific breakthroughs to life-changing therapies.

When Measuring Filter Performance, Is Performance Absolute?

Learn why high-performing filters are inadequate for critical filtration processes and sterilizing-grade filters are necessary to effectively remove undesirable species, including bacteria and viruses.

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.

Characterization Of Residual Impurities In Gene Therapy Drug Products

This expert discussion focuses on residual impurities for gene therapy drug products, risk assessment, and characterization of product-related impurities in LVV based gene therapy products.

Building A Fully Single-Use Process: Protein A Membrane Devices

Learn how a fully disposable upstream and downstream platform process in antibody production can increase production timelines, enhance scalability, and reduce risk in biologics manufacturing.

Sustainability Goals Impacting Biopharma

What are some of the new trends in the pharmaceutical industry spurred on by mAbs and other advanced therapies, and how is sustainability influencing business practices?

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.

Process Intensification And Connected Processing For mAb Manufacturing

Here, we present a proof of concept, demonstrating how a batch process for mAb purification can be transformed into an intensified process and then a connected process in a strategic, stepwise manner.

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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 Scale-Up And GMP Manufacturing - Cytiva

Virus Purification Resin Selection Card - Bio-Rad Laboratories, Inc.

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

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Webinar: Improve Bioprocess Freezing Outcomes with Analytics and Testing Services

Join us on August 26th to learn how reducing early phase inefficiencies can lower initial investments, significantly lower operations costs, and increase productivity. We will share case studies focused on benchmark testing, using surrogate materials, controlled rate freezing, and at line analytics, to identify potential impacts critical to quality, faster and without extensive analytic burden. Click here to learn more.

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Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific.

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