Newsletter | July 17, 2025

07.17.25 -- CDMO Opportunities And Threats Report

SPONSOR

Get ready for ISPE’s largest event of the year, the 2025 ISPE Annual Meeting & Expo, 26–29 October, in Charlotte, North Carolina, USA, and virtually. This year’s theme is Pharma 4.0™, with sessions exploring the integration of digitalization across all stages of pharmaceutical processes. Attendees can explore the latest advancements, network with like-minded professionals, and discover new technologies. Learn more and register.

FOCUS ON OUTSOURCING

June 2025 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

ADCs – From Bioassay Development To Linker-Payload Constructs

Antibody-Drug Conjugates (ADCs) are a promising class of targeted cancer therapies. Explore linker-payload design elements, characterization of ADCs, and the bioassays used to screen ADCs.

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.

AAV Analytics: Key Considerations When Developing A Clinical Program

Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Explore the 3 phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

SPONSOR

Webinar: Accelerating Tech Transfer with Integrated, Client-Focused Project Management

Join this upcoming Samsung Biologics webinar to learn how strategic project management speeds up drug substance (DS) and drug product (DP) tech transfers. Discover how co-locating DS and DP, early issue resolution, and strong team collaboration can shorten timelines, improve communication, and support faster regulatory approvals—even for complex biopharma projects. Click here to learn more.

OUTSOURCING SOLUTIONS

Making What Matters - Simtra BioPharma Solutions

Capacity Update April 2025: Fill/Finish - Catalent

Microbial Capabilities - AGC Biologics

Your AAV CDMO Partner, Every Batch, Every Milestone - MilliporeSigma

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