Newsletter | February 26, 2026

02.26.26 -- January 2026 — CDMO Opportunities And Threats Report

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Navigate therapy production complexities with solutions spanning every development stage. PrimePath is a comprehensive cell and gene portfolio including media and reagents, recombinant growth factors and proteins, specialty chemicals, critical assay materials, services, testing, and more. From discovery and research through clinical development to commercialization, the right partner matters. Discover how PrimePath supports your current and future needs at every phase of therapy development.

FOCUS ON OUTSOURCING

January 2026 — CDMO Opportunities And Threats Report

In conjunction with PharmSource, part of GlobalData, the first report of the year “Contract Manufacturing: Opportunities and Threats (CMOT) Report” is available now. The report identifies key events affecting CDMOs, including company acquisitions, product acquisitions, licenses, and approvals, late clinical product terminations, and FDA rejections.

Detecting Particles In Biologic And CGT Drug Products

Mitigate risk by identifying visible and subvisible particles in your pipeline. This webinar outlines characterization techniques essential for maintaining purity in cell and gene therapies.

Accelerating The Development And Scale-Up Of mRNA Vaccines

Learn how downstream considerations can make the difference between success and failure on the path towards the commercialization of mRNA vaccines.

From Promise To Patients: Smarter Pathways To Scale Manufacturing

As CGT evolves, your manufacturing strategy is as vital as the therapy itself. Delve into how developers are utilizing smarter scaling models to reach patient populations more efficiently.

Platform Optimization For AAV Manufacture Efficiency

Discover the platform that demonstrates a 30-fold increase in AAV yields while cutting costs by 85%. Review the data on how this scalable approach improves capsid quality and manufacturing purity.

Advanced Sequencing For Comprehensive AAV Vector Characterization

Short and long-read sequencing provide critical data on vector integrity and impurities. See how these complementary approaches improve the safety and regulatory profile of gene products.

Complexities And Pitfalls In cGMP Tissue Sourcing

Procuring the “right human tissue” is fraught with misconceptions. Review the complex sourcing elements required to meet BLA standards and ensure consistent cell quality and count.

Key CMC Step For Cell Therapy IND Success

Regulatory approval hinges on manufacturing consistency. Find the balance of the safety, quality, and potency benchmarks required to support a successful IND filing and subsequent clinical progression.

Maximize Starting Material Consistency

By implementing an efficient characterization strategy, researchers can enhance the consistency of allogeneic cell therapy starting material, ultimately leading to improved clinical outcomes.

Capital Constraints In CDMO & Pharma M&A

Tighter investment conditions are forcing a shift toward selective M&A and disciplined partnerships. Explore how current capital constraints are reshaping long-term outsourcing strategies.

xRNA Production: The Economic Case For Continuous Manufacturing

Continuous manufacturing can reduce production timelines to days. Evaluate the economic impact of real-time quality control and cost-cutting measures for next-generation xRNA therapeutics.

New Standards For Elastomeric Components In Sterile Packaging

Updated USP standards shift the focus to full system-level evaluation. Understand the new compliance responsibilities for drug developers regarding packaging integrity and usability.

OUTSOURCING SOLUTIONS

Advantages Of Our Expertise In Proprietary Cell Lines - IDT Biologika

Capacity Update: Large Molecule Drug Substance - Novartis Contract Manufacturing

The Platform For LLV Scale-Up And Transfer - Landmark Bio

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