Newsletter | October 21, 2025

10.21.25 -- Program Management's Role In Cutting Timelines And Hedging Against Failure

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Webinar: Advancing with confidence: smarter CMC strategies to accelerate next-generation biologics to the clinic

Unlock success in next-generation biologics development with Lonza. In this webinar, our experts share real-world case studies and practical CMC strategies to avoid pitfalls, reduce risk, and keep timelines on track. Learn how smart design, cross-functional collaboration, and CDMO partnerships accelerate progress from early development to first-in-human manufacturing—delivering innovative therapies to patients faster. Register now! Click here to learn more.

FOCUS ON OUTSOURCING

Defining Strong Program Management In CDMO Partnerships

This first article of a planned three-part series discusses the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and more.

Handling Protocols: Key Considerations In The Highly Potent API Market

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

Navigating The Complexities Of Pre-Filled Syringe Manufacturing

Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

Mastering Technology Transfers: Our Blueprint For Success

Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

Tips For Successfully Scaling From R&D To Manufacturing

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

Ophthalmic Drug Delivery

Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

How To Bring (Any) mRNA To Life: Simplifying Nucleic Acid Encapsulation

New technologies for the encapsulation of nucleic acids, such as FDmiX, can potentially overcome limitations of currently available standard mixing technologies.

Enabling Novel CRISPR-Cas9 Delivery: Supporting Innovative Genomics

An institute researching CRISPR-based genome editing required a custom, highly pure, ultra-low endotoxin nuclease. Learn how Aldevron's expertise helped to demonstrate reduced immune responses compared to using AAV serotype 9 for delivery.

A Non-Viral Workflow For Modifying Primary T Cells

This study demonstrates the ability of combined platforms with complimentary technologies to modify primary T cells in a functionally-closed, automated fashion.

Idea To Clinic: Accelerate Your Manufacturing Timeline To FIH Studies

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.

Why Use Transposase Technology For Expression Of Your Biotherapeutics?

Discover how a proprietary transposase technology works and why it can be beneficial for the development process for the expression of biologics.

UpTempo: Seamless Transitions From Bench To CGT Applications

Accelerate cell and gene therapy development with high-yield, regulatory-compliant plasmid DNA manufacturing that shortens timelines, minimizes risks, and streamlines your supply chain.

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Developing new delivery routes for biological therapies is essential for creating more patient-centric and effective treatments. By using nanoforming techniques, it's possible to simplify dosing regimens and enhance patient comfort, compliance, and even reduce overall healthcare costs. Find out how this is best demonstrated through two real-world examples. Learn more

OUTSOURCING SOLUTIONS

Advancing Vaccines From Preclinical To Commercial Supply - FUJIFILM Biotechnologies

UpTempo AAV Platform Process - Catalent

Services Designed To Take You From Molecule To Market - Cytiva

Capacity Update April 2025: Fill/Finish - Mabion

Capacity Update July 2025: ADC - Simtra BioPharma Solutions

Advancing CRISPR-Based Therapeutic Development - Aldevron

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