Newsletter | September 10, 2026

09.10.26 -- In Vivo CAR T Needs More Than Better Cell Engineering

SPONSOR

Webinar: Annex 1 in Practice: Turning CCS Into Cleanroom Design

How can facility design help prevent contamination before it threatens product quality? This AES webinar explores how EU GMP Annex 1 and a proactive Contamination Control Strategy (CCS) can shape cleanroom design, airflow, barrier technology, personnel and material flow, and aseptic processes. Learn how embedding contamination control from concept through operation can reduce regulatory risk and support inspection-ready manufacturing facilities. Click here to learn more.

FOCUS ON MANUFACTURING

In Vivo CAR T Needs More Than Better Cell Engineering

In vivo CAR T’s potential to expand access and simplify manufacturing hinges on targeted LNP delivery and solving the durability challenge.

Automated Centrifugation Fixes Manual Cell Therapy Losses

A closed, automated centrifuge system achieves consistent cell recovery and viability across leukopak donors and wash media, addressing key limitations of manual cell therapy processing.

Plasmid DNA Purification: Strategic Steps For Scale

Identify optimal conditions across chromatography media to maximize plasmid DNA recovery and remove critical impurities during large-scale biomanufacturing processes.

Robotic Fill-Finish Systems Reduce Small-Batch Risk

Modernize sterile production with robotic fill-finish technology that delivers multi-format flexibility and risk reduction for personalized medicine manufacturing and small-batch production demands.

Automated Manufacturing Of CD34-Enriched Cell Products

Integrate thawing, washing, and enrichment into a single automated workflow to reliably produce high-quality CD34+ cell products from cryopreserved apheresis material.

Discover A System That Can Be Used With Various Cell Culture Media

Evolving CAR T cell therapies are raising the bar for manufacturing. Advances in cell expansion and the shift to serum-free media are redefining how scalable, future-ready processes are designed.

How To Select The Right Platform For Your Vaccine Production Process

Evaluate surface treatments, scalability, and contamination risks to select the right adherent platform. Testing early ensures a seamless transition from benchtop to production.

Why Gene Therapy Biodistribution Demands Precision ddPCR

ddPCR is becoming essential for biodistribution because it delivers precise, low‑copy quantification that qPCR can’t reliably match. Sponsors need partners with ddPCR depth across tissues and studies.

Quality By Design Meets Digital QMS In Advanced Therapies

Risk-based systems, proactive problem-solving, and digital QMS tools drive operational excellence, deviation management, and compliance across biomanufacturing workflows.

GMP Raw Material Strategy: Mitigating Contamination Risk

Explore the critical aspects of GMP-grade raw materials in CGT manufacturing, including contamination control, aseptic strategies, quality systems, supply chain security, and regulatory compliance.

From Gene Editing To NGS-Based T Cell Characterization

Gene-edited T cells targeting PD-1 and TIGIT are redefining approaches to cancer therapy. See how cell engineering and integrated genomic workflows uncover critical insights into T cell function.

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.

Scalable Lentiviral Vector Supply Accelerates CAR-T Care

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

SPONSOR

Webinar: Scaling AAV manufacturing to 1000 L: strategies for robust and reproducible production

Moving AAV manufacturing from development to commercial scale requires more than simply increasing volume. Discover how integrated cell line, media, and bioreactor strategies can optimize transient AAV production, improve process robustness, and maintain product quality. This Cytiva webinar shares scale-up insights and a 1,000 L case study showcasing practical approaches for accelerating manufacturing-ready viral vector production. Click here to learn more.

MANUFACTURING SOLUTIONS

Scalable Freezing And Thawing For Development And Manufacturing - Single Use Support

High-Quality Raw Materials For CGT Manufacturing - Roche CustomBiotech

Viral Vector Manufacturing Services Tailored For You - Cytiva

Streamline Your Path With Coordinated Solutions And Services - FUJIFILM Biotechnologies

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