Newsletter | June 9, 2026

06.09.26 -- FDA Now A Supply-Chain Complication

INDUSTRY INSIGHTS

Reducing Variability With Animal‑Origin‑Free Peptones

Explore how data‑driven collaboration and animal‑origin‑free media strategies can reduce variability, improve cell culture performance, and support consistent, cost‑effective bioprocessing at scale.

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.

Circular Single-Stranded Cell-Free DNA For Next-Gen Gene Editing

Next‑gen circular DNA payloads enhance gene insertion by improving stability, lowering cytotoxicity, and enabling precise, scalable integration across HDR, recombination, and transposition systems.

FEATURED EDITORIAL

FDA Now A Supply-Chain Complication

Crossing the Rubicon to regulatory-leadership discontinuity; suffering a disunity at the FDA impacting our supply chains. When sponsors begin altering outsourcing relationships and clinical-trial strategies because of uncertainty at the FDA, more supply-chain challenges are created than corrected for. That suggests all of us should take a deep breath. Vigilance and concern are always part of the drug industry. But we need to address the question: How is the FDA impacting development and manufacturing outsourcing?

What Reliance, Annex 1, And AI Mean For The Future Of GMP

EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

What If The U.S. Government Stopped Funding Biotech?

It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.

INDUSTRY INSIGHTS CONTINUED

What Sponsors Get Wrong When Selecting A CRO

Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results.

The Crucial Role Of Apheresis In Cellular Therapies

Focusing on quality, the presenters will discuss the importance of adhering to collection protocols and the real-world effects on treatment outcomes.

Add mRNA Capacity

Learn about a platform that addresses five critical pain points to help mRNA manufacturers flexibly scale while improving the digital maturity of their sites.

Nucleic Acid-LNP Ultrafiltration And Diafiltration

Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.

Accelerate Your Trials With An End‑To‑End Supply Chain Model

An end-to-end supply chain model helps clinical trials move faster while maintaining visibility, control, and risk management across complex, temperature‑sensitive, and global operations.

SPONSOR

Outsourced Pharma Capabilities Update - Cell Therapy

Join us on June 16th for a virtual event on cell therapy manufacturing and CDMO selection. Experts will discuss how early development decisions affect scalability, GMP manufacturing, tech transfer, supply chains, and commercial readiness. The session explores strategies to reduce downstream risks like inconsistent quality and operational delays. Intended for CMC, manufacturing, quality, regulatory, supply chain, and procurement professionals evaluating cell therapy outsourcing partners. Click here to learn more.

SOLUTIONS

A New Era Of Onsite CAR‑T Manufacturing

Inside The Latest Cell And Gene Therapy Expansion Efforts

Building Momentum In Cell And Gene Therapy

Comprehensive mRNA Solutions

A One-Minute Look At A Next-Gen Cell Therapy Platform

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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