Newsletter | August 13, 2025

08.13.25 -- Challenges And Considerations For Purifying Multispecific Molecules

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Turn complexity into clarity and obstacles into outcomes. Get your process intensification implementation strategy right the first time by using our process design tools and stepwise consultancy services to predict cost, processing times, and productivity gains for your entire manufacturing process. Learn more here.

FOCUS ON DOWNSTREAM MANUFACTURING

Challenges And Considerations For Purifying Multispecific Molecules

The structural complexity and variability of multispecific molecules presented purification challenges, from incorrect chain pairings to increased aggregation, fragmentation, and lower yield compared to standard mAbs. Developers shared how they overcame these challenges to achieve high purity and discussed key considerations for downstream developers when designing these processes.

Optimize Your mAb Capture And Polishing With The Latest Resins And Tips

Discover the latest innovations in monoclonal antibody purification and explore resin selection strategies to optimize product quality and improve process efficiency.

Scalable Expansion And Downstream Processing Of High-Quality hiPSCs

Learn about a scalable, microcarrier-based 3D culture process for expanding hiPSCs to 10L, yielding over 10 billion cells while maintaining quality.

Navigating Downstream Bioprocessing For Biosimilar Development

Unlock efficient biosimilar production with expert insights that reveal how advanced purification technologies can significantly reduce costs and meet stringent regulatory demands in today's market.

Toward A Gene Therapy Platform: What's The Best Format Of TFF?

Evaluate tangential flow filtration (TFF) formats and membrane chemistries for AAV gene therapy processing, assessing performance, scalability, economy, and closed processing options.

Optimize Your Chromatography Process With Purpose-Built Connections

Downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. CPC designers identified a polymer to handle rough downstream chemicals.

Achieve Downstream Process Improvements Through Buffer Management

Understanding the alternative buffer management and preparation strategies available can ensure you have the tools and resources to remain competitive in today’s growing bioprocessing industry.

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.

DOWNSTREAM MANUFACTURING SOLUTIONS

Groundbreaking Nanoparticle Processing Technology - DIANT Pharma

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

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

FOCUS ON FILL-FINISH

ITC: Unveiling Its Role And Importance In Drug Design

Learn how Isothermal Titration Calorimetry empowers drug discovery, as well as learn ITC fundamentals, eliminate weak candidates, and optimize development decisions for researchers and scientists.

Vial Fogging: Practical Considerations For Vial Selection

Vial fogging is a common phenomenon observed in lyophilized biologic drug products. Dive into two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

Expanding Opportunities For Inhaled Drug Delivery

Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines

Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.

FILL-FINISH SOLUTIONS

Multiplexing Optical Methods For Protein Characterization - NanoTemper Technologies, Inc.

Unlocking The Potential Of Your Sterile Injectable - Pfizer CentreOne

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