Newsletter | September 1, 2026

09.01.26 -- Lower Court Agrees With WuXi AppTec (And Many Of Us)

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Viral Vectors | Sept. 29, 2026

This session examines the latest strategies, tools, and technologies shaping viral vector development and manufacturing for gene therapies. Attendees will learn how advances in vector design, process development, and production are improving safety, potency, scalability, and regulatory readiness. The discussion will also cover common manufacturing challenges and provide guidance for selecting experienced CDMO partners to support efficient, reliable viral vector production. Learn more.

INDUSTRY INSIGHTS

 

The Future Of DNA Production: Speed, Scalability, And Cell-Free Innovation

Replace traditional plasmid manufacturing with cell-free enzymatic production for scalable, cost-efficient development free of bacterial backbone sequences.

 

Why A Strong CMC Roadmap Is Essential For Cell Therapy Program Success

A structured regulatory roadmap and early management of manufacturing, materials, and assay testing help reduce risk and prevent costly delays in cell therapy development.

 

Improving LVV And AAV Yield Through Cargo Gene Silencing

Silencing cargo gene expression during LVV and AAV production improves cell health, reduces impurities, and significantly increases vector yield for cytotoxic and difficult‑to‑manufacture transgenes.

FEATURED EDITORIAL

Lower Court Agrees With WuXi AppTec (And Many Of Us)

A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.

 

Insights Into How Sponsors Search Today For CDMOs

An AI-driven CDMO search tool is returning insights into how today’s sponsors select external supply-chain partners. Aptly dubbed CDMO Signalthe application aggregates FDA inspection data, clinical trial records, SEC filings, and various other attributes across over 150 CDMOs. We've noticed at least three intriguing search threads originating from this newly created search tool.

How Shelved Orphan Drug Candidates Can Find A Path Back To Development

The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

INDUSTRY INSIGHTS CONTINUED

 

Setting A New Standard For Biotech Program Visibility

Biotech visibility improves through real-time data and centralized platforms, enabling collaboration, faster decisions, reduced risk, and better partner alignment.

 

Engineering Precision In Genetic Medicines

Precision genome editing strategies that balance specificity and potency through advanced engineering workflows, AI‑driven optimization, and tailored editor design for clinical genetic medicines.

 

Myths That Make Early CDMO Engagement Look Like A Risk

Early CDMO engagement isn’t premature—it prevents CMC-driven delays, reduces comparability risk, and aligns AAV manufacturing decisions with long-term clinical and commercial success.

 

Eliminating Barriers To In Vivo And Ex Vivo CAR-T Delivery

Learn how lentiviral vector processes evolve for in vivo and ex vivo CAR‑T—covering yield, purity, scalability, and shifting regulatory demands for safe, consistent systemic delivery.

 

How To Design And Evaluate Bispecific Antibodies (BsAbs)?

Bispecific antibodies combine two antigen-binding sites to enhance efficacy and safety. Their design requires structural strategy, MOA-based evaluation, and screening for optimal therapeutic performance.

 

A Scalable Platform For Lentiviral Production

Review the results obtained for our proprietary HEK293T 2G7 suspension cell line for LVV production by transient transfection in serum-free, chemically-defined and animal component-free media.

 

Capital Constraints In CDMO & Pharma M&A

Capital constraints are reshaping CDMO and pharma strategies, driving selective M&A, prioritizing partnerships, and enforcing financial discipline amid tighter investment conditions.

SOLUTIONS

Accelerating Drug Development Through Integrated Partnership

Plant-Based Peptones For Bioprocessing

Simplify Your mRNA Workflow From The Start

Bioprocess Training And Education

What Sets AVV Apart?

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

 

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