Genetically Modified Cells

AGC Biologics offers tailor-made services for cell & gene therapy projects, providing the highest clinical and commercial standards for ATMP. Our services include technology transfer, development, scale-up, automation and validation of retroviral / lentiviral cell transduction processes, as well as realization of the medicinal product.

We offer the development, qualification and validation of complex analytical tests.

We have supplied 300+ patients for 30+ C&GT clinical trials and commercial purposes.

technology transfer

  • Extensive experience performing tech transfer, development, scale-up, automation and validation activities for both proprietary and third-party cell engineering platforms

Process development and analytical methods development

  • We develop and optimize customer processes for both clinical and commercial products

GMP manufacturing

  • Proprietary processes for manufacture of genetically engineered HSC (CD34+) and T-cells, for both autologous and allogeneic products

quality control

  • Over 100 in-house vector tests reduce costs and save time (safety, identity, potency, purity) on IPC and DS/DP
  • Our internal QPs perform the drug product release

QA and regulatory support

    • Quality management systems are aligned with EU ATMP GMP and FDA guidelines
    • Support with regulatory agencies