Newsletter | December 11, 2024

12.11.24 -- USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli

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Strategies to Address Biomolecule Purification Challenges

Large molecule purification presents significant challenges due to their considerable size. For instance, IgM molecules play pivotal roles in mammalian immune responses and find extensive applications in diagnostics and therapeutics. Watch this on-demand webinar that explores innovative strategies for overcoming challenges in plasma protein and virus purification using design of experiments methodologies, focusing on real-world applications that enhance productivity and process economics in large molecule purification.

FOCUS ON FILL-FINISH

Addressing The Challenges Of Late-Stage Aseptic Manufacturing

Gain insight into the current landscape of filling and late-stage manufacturing from a survey of 78 professionals from top companies in the industry.

Optimizing And De-Risking With Real-Time, Viable Environmental Monitoring

Real-time, viable environmental monitoring is optimizing manufacturing timelines via immediate results, alleviating risks associated with traditional monitoring methods, and satisfying Annex 1 regulations.

Expanding The Boundaries Of Sub-Cutaneous Injections

As the field of biologics increases its focus on identifying new diseases to target and novel constructs to treat them, innovative administration devices are once again in the spotlight.

Manufacturing Challenges With High Concentration Biologics

Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

FILL-FINISH SOLUTIONS

Peristaltic Pump Configuration Saves Days Of Production Time - Avantor

Minimizing Uncertainty Throughout The Development Lifecycle - West Pharmaceutical Services, Inc.

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Following its popular inaugural 2024 Bio-Expo Live, Bioprocess Online brings you the next opportunity to advance your drug development agenda. Over just a small portion of your week and from the comfort of your computer, discover the latest solutions in upstream and downstream bioprocessing as well as bioprocess quality, data, and analytics. 15-minute presentations from leading suppliers will give you just the right insight to make your next best move in drug development. Register here.

FOCUS ON DOWNSTREAM MANUFACTURING

USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli

Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.

A Complete "How-To" Guide For Saliva Collection And Testing

This complex biofluid plays a critical role in human physiology and disease pathophysiology. Gain a better appreciation for saliva and its growing use.

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.

Low Volume Liquid Measurement Testing With An Automated Workstation

Explore performance testing results obtained at the Biomek i-Series Automated Workstation's low volume range capability, which demonstrate a process for achieving optimized low-volume pipetting performance.

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.

Selecting Optimal Chromatography Resins To Support mAb Purification

Discover key considerations when selecting resin options for mAb purification, including alternatives to the conventional affinity capture step.

Simplify Adoption With A Multi-Column Chromatography System

See a multi-column chromatography system in action with your product and process. Learn how you can simplify adoption and optimize your process faster with step-by-step expert support.

How Scale-Up Benefits A Clinical Program To Get Results

A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market.

Optimizing Chromatography Media In Bioprocessing

How can you optimize your media for chromatography and improve consistency, yield, and purity through the integration of automation technologies such as advanced slurry preparation systems?

A Faster And More Economical Path To Investigational New Drug Applications

Read how new membrane-based protein A affinity chromatography technology can greatly shorten the time it takes to get to IND while also making the process less expensive and more adaptable.

DOWNSTREAM MANUFACTURING SOLUTIONS

A Pilot-Scale, Sedimenting Centrifuge - CARR Biosystems

Chromatography Resins For Lab To Process Scale Purification - Ecolab, Purolite Resins

Spaulding Aseptic Disconnects - Nordson MEDICAL

Protein L Mix-N-Go ELISA Kits - Cygnus Technologies Inc.

High Binding Capacity And Short Residence Time For Antibody Purification - W.L. Gore & Associates

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