10.20.25 -- 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.

By implementing an efficient characterization strategy, researchers can enhance the consistency of allogeneic cell therapy starting material, ultimately leading to improved clinical outcomes.

Through real-world case studies, we highlight how AI-driven tools enhance gene therapy, providing case studies and addressing the challenges and prerequisites for successful implementation. 

Establishing a CGT product for regulatory viability and commercial success requires strategic investment in process design, along with well-coordinated planning of PPQ and CPV activities to ensure readiness.

Explore the rigor required across the product lifecycle, from evaluating feasibility in preclinical studies to establishing validated release methods and implementing lifecycle management in commercial supply.

From enabling insights through donor characterization to reducing manufacturing variability through cell separation technologies, delve into real-world case studies and actionable approaches to scale smarter.

The AAV transient transfection platform helps de-risk the path to IND by minimizing complexity and shortening timelines typically associated with extended process and analytical development efforts.

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Using a design of experiments (DOE) approach, we optimized transfection conditions to improve rAAV yield and quality, successfully scaling with single-use bioreactors.