Newsletter | September 4, 2025

09.04.25 -- Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter?

SPONSOR

Join the 5th iPSC Drug Development Summit, October 1-2, in Boston - your go-to event for uniting iPSC drug developers across R&D to CMC. Hear from 30+ expert leaders from Aspen Neuroscience, Novo Nordisk, BlueRock Therapeutics and more, as they share their expertise across two tracks: Preclinical or Process Development & CMC. If you are a drug developer or an academic, you can claim a complimentary pass. Register here

FOCUS ON OUTSOURCING

Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter?

This continues our discussion of AI and CDMOs, focusing on biologics and cell and gene therapy (CGT) relationships. Outsourced Pharma Board Member Vadim

6 Key Questions When Selecting Your Cell Banking Manufacturing Partner

Evaluating a potential cell banking partner's experience, testing capabilities, and approach to material management can help guarantee the quality and consistency of your therapeutic cells.

IND-Enabling Programs For Adoptive Cell Therapies

Accelerating the development of adoptive cell therapies through robust preclinical strategies and regulatory pathways is crucial to bringing these life-saving treatments to patients in need.

Phase-Appropriate Approaches To Manufacturing And Testing

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

AAV Viral Titering Using Nanoplate-Based Digital PCR

Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

Powering Cell Therapy Access: Louisville, KY's Unique Position

Discover why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

Why The Right Partnerships Are Key To Harnessing New Sterile Delivery Methods

By leveraging the expertise of CDMOs, pharmaceutical firms can expedite their time to market, reduce costs, and improve patient outcomes, ultimately advancing the future of drug delivery methods.

A Next-Gen rAAV Production Platform That's Revolutionizing Manufacturing

See how a next-generation rAAV production platform delivers high yields and superior product quality across various serotypes and genome lengths through innovative process optimization.

Effectively Enabling Rare Diseases To Reach Patients

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Securing INmune Bio's Trial Materials In A Crisis

Discover how a sudden biostorage shutdown put INmune Bio’s trial at risk, revealing the critical importance of logistics and rapid coordination in protecting advanced therapy programs.

Our Analytical And Quality Control Strategy For Your Therapies

A comprehensive Quality Risk Analysis and Control Strategy is built on five key pillars, each playing a vital role in ensuring that every final product meets the highest safety and efficacy standards.

OUTSOURCING SOLUTIONS

Viralgen Capacity Update July 2025: Cell & Gene Therapy - Viralgen

CHO Cell Line Development Services For Therapeutic Protein Development - Sartorius

See How We Bring Biotech Innovation To Life! - 3PBIOVIAN

Gene Therapy Innovation From Platform To Process - Ascend & ABL Inc.

GS Effex® Cell Line For Enhanced Antibody Effector Function - Lonza

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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