Newsletter | November 10, 2026

11.10.26 -- Is Your Supply Chain Ready For The End Of Class VI?

SPONSOR

Webinar: Decoding Biologics Tech Transfer: Guiding process performance across sites, scales, and bioreactor systems

Tech transfer isn't just moving a process from one place to another. It's about ensuring process understanding and control can withstand changes in scale, equipment, sites, and teams. Discover how bioreactor characterization, scale-down models, in-silico modeling, and cross-site collaboration can uncover uncertainty before it becomes manufacturing risk and help protect product quality and timelines. Learn more.

FOCUS ON OUTSOURCING

Is Your Supply Chain Ready For The End Of Class VI?

Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

A Proven And Globally Adopted Disposable Pen

Gain insight into a disposable pen that is a proven, globally adopted drug delivery platform with over 175 million units sold, supporting diverse therapies in 40+ countries.

Building A Biomanufacturing Ecosystem For Supply Agility Starts Early

A unified, modular biomanufacturing ecosystem combining rapid CLD, flexible purification, and scalable global capacity can accelerate production and strengthen supply agility amid rising demand.

How Characterization Analytics Smooths The Path To IND

Smart analytical decisions made early can prevent costly issues later. Real-world examples show how right-sized analytics enable smoother scale-up and fewer late-stage surprises.

Predictable Outcomes Ensuring Success With A Dual-Site Model

Technology transfer succeeds through trust, shared knowledge, and disciplined execution. See how collaboration, strong documentation, and digital tools reduce risk on the path to GMP.

Overcome Early Development Challenges Before They Impact Your Program

Poor manufacturability and immunogenicity can delay development. Learn how early developability assessments support IND readiness.

Why CDMO Outsourcing Is Moving Earlier In Biologics Development

Engaging manufacturing partners earlier in biologics development mitigates critical scale-up risks. Explore how aligning technical strategies early preserves process history and simplifies compliance.

Bridging Discovery, Developability, And Commercial Reality

Driven by metabolic and oncology successes, the expanding peptide therapeutics market faces critical challenges requiring early, customized drug product development, stability, and safety strategies.

The 5 Key Risks Of Failing To Select The Right CDMO Partner

For complex projects involving oral solid dosage (OSD) and sterile drug products, selecting the ideal CDMO can play a pivotal role in determining the success of a drug candidate.

Negative Stain TEM For Viral Particle Characterization

Standardized latex bead references combined with negative stain TEM provide precise viral particle characterization and consistent viral load quantification.

OUTSOURCING SOLUTIONS

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Non-Viral Delivery Of Complex Cargos For Large-Scale CAR-T Manufacturing - Lonza

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Integrated Culture And Fermentation Systems - Boehringer Ingelheim Biopharmaceuticals GmbH

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Digital Solutions To Solve Manufacturing And Tech Transfer Challenges - Emerson

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Our Development Approach - Recipharm

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Capabilities Update July 2026: Large Molecule - Avid Bioservices

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Quality With Purpose: From Manufacturing Excellence To Patient Impact - Grand River Aseptic Manufacturing

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Capabilities Update June 2026: Cell Line Development - Abzena

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