10.28.25 -- Cell & Gene Therapy Outsourcing's New Paradigm

To prevent path-to-market setbacks, it is critical to develop a Chemistry, Manufacturing, and Controls strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

Early product characterization can serve to uncover crucial information about an advanced therapeutic candidate, affording new insight into its CQAs and helping to shape better analytical assays.

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

In this presentation, our cell and gene experts explore innovations in viral vector manufacturing, production challenges, quality control strategies, and tech transfers.

Discover how one family defied the odds — bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Watch as speakers discuss the critical importance of integrated distribution strategies in successfully commercializing cell and gene therapies, also sharing insights on distribution partnerships.

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

Uncover how a diverse collection of RNA-guided nucleases, base editors, and reverse transcriptase editors with unique PAM recognition sequences can enable flexible and precise genome editing.

Leverage mass photometry to quickly and accurately monitor the full-to-empty ratio of rAAV samples, ensuring consistent product quality and enhanced safety and efficacy in gene therapy applications.

This study evaluates the performance and productivity of VintaProcess in addressing the persistent manufacturing challenges in AAV gene therapy production.

Explore two projects that a focus on improving efficiency and productivity in biopharmaceutical manufacturing while reducing the cost of goods through process intensification.

CAR-T cell therapy is poised to transform cancer care in India, with new initiatives aiming to make this breakthrough treatment both clinically feasible and financially accessible.

Gain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.

Senior Key Account Manager, Dr. Jürgen Lübbehusen, highlights IDT Biologika´s overall fill-finish capabilities and capacities, with a focus on our ability to help meet your complex needs.

Witness how an intensified adherent AAV manufacturing process is unlocking high-yield, low-impurity clinical production with over 95% full capsids in a streamlined, compact platform.

As a leading CDMO in AAV manufacturing, Viralgen facilitates rapid transition to cGMP with a proven platform and an impeccable 100% IND success rate. Discover how Viralgen drives industry progress.

By combining disruptive technology platforms with unparalleled genomic medicine development expertise, we're positioned to accelerate the development of LNP formulations and drug products.

Build the most relevant cell line for your studies with the ability to insert 20+ kb of DNA site specifically, in single copy, and at efficiencies approaching 100% after selection.

Our flexible partnership models empower you to scale efficiently and confidently — whether advancing a single molecule or managing a complex portfolio of therapeutic candidates.