Newsletter | November 19, 2025

11.19.25 -- Common Manufacturing Challenges For LBP Formulations

SPONSOR

Reliable TFF with Pellicon® Cassettes

Enhance your biomanufacturing with Pellicon® 3 Cassettes, designed for reliable tangential flow filtration. Produced in Blarney, Ireland, these cassettes ensure supply chain resilience while delivering high product yield and consistent purity. With broad chemical compatibility and engineered for demanding conditions, Pellicon® 3 Cassettes support seamless scale-up from lab to full-scale production. Experience the benefits firsthand—request your free sample today and optimize your filtration processes for mAbs, vaccines, and more!

FOCUS ON DOWNSTREAM MANUFACTURING

Common Manufacturing Challenges For LBP Formulations

As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

Merck Process Transfer And Scale-Up Of Batch Protein A

Explore cost-saving innovations in purification using a system that achieves consistent product quality and yield while significantly reducing resin use and enhancing large-scale efficiency.

Optimize Your Process For Producing High-Concentration Drugs

Uncover the challenges and solutions in high-concentration mAb manufacturing, which includes practical strategies for maximizing product recovery and optimizing processes for efficient production.

Implementing A Versatile Mixing System To Drive Down Costs

Learn how a CDMO reduced capital expenses and operational complexity by adopting an all-in-one mixing solution that supports every stage of production and a wide range of volumes.

Increased Productivity At Multiple Scales With Rapid CIP

Read through a demonstration of a rapid CIP being utilized to optimize the loading and non-loading residence times during cycling to achieve increased productivity on a specific capture device.

Future Proof Your Process Scale Workflow

Discover how to build a scalable bioprocess workflow from foundational steps to tangential flow filtration, as well as how to reduce risk, improve consistency, and future-proof your operations.

A Practical Guide To Single-Use Filtration In Biopharma

In the evolving world of biopharmaceutical manufacturing, gain insight into how single-use filtration remains a vital yet overlooked process essential to ensuring product purity and patient safety.

DOWNSTREAM MANUFACTURING SOLUTIONS

Drug Product Filtration System - Cytiva

Fully Automate Processes With A Suite Of Integrated Hardware Components - Repligen

Protect And Extend UHPLC, HPLC And PREP Column Lifetimes - Danaher Life Sciences

A Trusted Resource For Biotherapeutic Purification - Bio-Rad Laboratories, Inc.

Advanced Purification To Improve Your Manufacturing Efficiencies And Timeline To Clinic - Ecolab, Purolite Resins

SPONSOR

Webinar: Unlock Productivity in mAb Production: Upstream and Downstream Intensification

Discover how Thermo Fisher Scientific is transforming monoclonal antibody (mAb) production through next-generation process intensification technologies. This webinar highlights innovative upstream and downstream strategies—from high-density cell banking and optimized CHO-K1 media to single-use systems and in-line dilution technologies—designed to streamline workflows, reduce costs, and significantly enhance efficiency across every stage of modern mAb manufacturing. Click here to learn more.

FOCUS ON FILL-FINISH

Formulation Through Manufacturing Under One Roof

Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.

Formulating Better ASDs And mAbs: Advances In Applied Nanotechnology

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

Solving Aseptic Filling Challenges For Your Advanced Therapeutics

Explore aseptic filling workcells, modalities, agency approvals, and insights from six expert users that offer a peer-driven look at industry innovation and benchmarks.

FILL-FINISH SOLUTIONS

Drug Product Manufacturing: Yield-Maximizing Technology - Argonaut Manufacturing Services

Microcalorimetry: RS-DSC, DSC & ITC - TA Instruments

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