Newsletter | August 18, 2026

08.18.26 -- Mission-Driven Professionals And Students Build America's Supply Chains

INDUSTRY INSIGHTS

Revolutionizing Lentiviral Vector Manufacturing For CAR-T Therapies

Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.

GLP Compliance In A Modern Lab: What Is Actually Required?

GLP compliance isn’t binary. Real defensibility depends on rigorous QA, validated electronic systems, and operational maturity — not just a label.

Built‑In Quality For Audit‑Ready Manufacturing

Pre‑approval inspection readiness requires embedding quality, traceability, contamination control, and analytical and documentation practices into everyday cell therapy manufacturing.

FEATURED EDITORIAL

Mission-Driven Professionals And Students Build America's Supply Chains

Tales of purpose-led careers that bring innovations to business leaders and opportunities to university students. They inspire us. Chief Editor Louis Garguilo documents two such professionals who have combined to help domestic manufacturing organizations locate each other and power their operations, and to get students involved in the industry.

Combination Cell Therapy's Clinical Success Hinges On Manufacturability

Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.

European CDMOs Surge Despite Shifting Global Trade Policies

Confirming data is now at hand. In 2025, we suggested Europe’s CDMOs couldn’t wait for a political or trade détente vis-à-vis the U.S. If they actively leveraged their reputation for reliability, tariffs would not meaningfully redirect manufacturing to the U.S. Here's an analysis of a GlobalData report on what has transpired.

INDUSTRY INSIGHTS CONTINUED

Redefining The Analytical Frameworks Surrounding Capsid Characterization

Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.

Empowering Antibody Discovery

Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification.

Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future.

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.

Building Confidence In Scalable LVV Manufacturing

Uncover a ready-to-use, suspension-based platform technology for transient transfection of LVVs that eliminates the need to transition from small-scale adherent processes.

How Operational Efficiency Shapes Late-Phase Manufacturability

Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.

AAV Upstream Process Development: High-Throughput To Clinical Scale

AAV manufacturing costs can exceed $1M per dose. See how DoE in a high-throughput system cut COGs by 60% and scaled AAV9 production to 2,000 L.

Unlocking Durable Allogeneic Cell Therapy

Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.

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.

Successful Upscaling Strategies For Viral Vector Manufacturing

Successful viral vector scale‑up depends on early process design, predictive models, and execution strategies that anticipate GMP realities rather than simply increasing production volume.

SOLUTIONS

Circular DNA Architectures For Advanced Gene Editing

Achieving Scale And Compliance In cGMP Cell Banking

CGT, Contract Development, Manufacturing, And Technology Solutions

Peptones, Hydrolysates, And Yeast Extracts

Accelerate Your Next In Vivo CAR-T Program

Unlock The Power Of mRNA With Analytical Testing

Single-Use System For Clinical And Commercial Production Of LNPs

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.

Connect With Outsourced Pharma: