Newsletter | June 5, 2025

06.05.25 -- To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions

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With over 30+ years of experience, Catalent offers a comprehensive suite of orthogonal GMP analytical services for all biological modalities, from discovery to commercial phases. Our seasoned experts ensure exceptional on-time delivery and client satisfaction by providing tailored solutions to meet your unique needs—no matter the complexity, scale, or timeline. Watch our intro video to learn more about our capabilities!

FOCUS ON OUTSOURCING

To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions

By Nathalie Huther, Ph.D., MBA; Carlos N Velez, Ph.D., MBA

In Part 1, we introduced the critical link between CMC and prospective investors and/or licensees. Here we conclude with suggestions for how CDMOs can lend expertise early in discovery/development to improve the probability of securing investment or license for their clients.

Characterizing The Effector Functions Of Therapeutic Antibodies

e-book | Labcorp Biopharmaceutical CMC Services

Gain a thorough understanding of the Fc region of your antibody product and how to use a risk-based approach to strategically test its functionality, optimize safety, efficacy, and development.

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

e-book | Nanoform

The pharma industry is identifying ways to make processes more sustainable. Learn how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

3 Keys To Success When Planning With Your CMO Partner

Article | Argonaut Manufacturing Services

Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible – while your product is still in preclinical or clinical development.

Secure Tech Transfers Of Biological Products In Sterile Manufacturing

Article | By Angela Armanni, Lonza

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

Idea To Clinic: Accelerate Your Manufacturing Timeline To FIH Studies

Webinar | Resilience US, Inc.

Translating novel drug discoveries into clinical trials remains a complex endeavor. Learn how a CDMO with cutting-edge technologies can facilitate a smooth path from discovery to FIH studies.

Transforming Rare Disease Drug Development For A Faster Cure

Webinar | FUJIFILM Diosynth Biotechnologies

This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

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Webinar: Fixing the Fixed: Unlocking Efficiency in Large-Scale Microbial Manufacturing

Commercial biomanufacturing isn't static—it's an evolving process. This webinar shares real-world case studies from Lonza’s microbial manufacturing facility, highlighting how continuous improvement is achieved through data-driven yield optimization, process refinement, and deviation analysis. Attendees will learn how to maintain agility, apply Six Sigma tools, and build resilience into operations to enhance efficiency, quality, and performance. Click here to learn more.

OUTSOURCING SOLUTIONS

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The Next-Gen Cell Line Development Platform Fueling Biologics Success - Abzena

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Excellence In Every Injection. - Pfizer CentreOne

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Capacity Update April 2025: Large Molecule Development - Catalent

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Our Capabilities - VintaBio

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