CGMP Cell Therapy Manufacturing CDMO Services
Are you ready to embark on a journey to the future of innovation in cell therapy?
Click on the link below for an exclusive virtual tour of our cutting-edge cell therapy suite for CGMP manufacturing!
Have you ever wondered how life-changing therapies are developed and produced? Want to explore the meticulous processes that drive innovation in cellular therapies? Step into the world of science, technology, and healthcare with us.
Autologous and Allogeneic Capabilities in One Site!
• Off-the-shelf or custom manufacturing of expression and packaging plasmids with clear title and non-restricted IP;
• Lentivirus manufacturing for gene-modification.
• SK pharmteco can either develop and optimize client-specific processes or tech transfer in established processes seamlessly transfer your manufacturing process;
• Utilize the same equipment and scale during development and tech transfer as in your CGMP facilities;
• Scale up with pilot and training runs in one location to advance your project to CGMP production;
• Draft electronic batch records in pilot runs for efficient debugging to de-risk CGMP manufacturing;
• Experienced program management team to provide clear oversight of your project through regular updates, on-site access, and the potential for dedicated office space onsite.
• For autologous cell therapy products, we employ sophisticated scheduling, supply chain and inventory control systems aligned with in-process testing, quality control, and lot release programs to overcome challenges. A structured process ensures integrity through Chain of Identity and Chain of Custody from receipt of donor/patient material to processing, storage, and shipment back to the Authorized Treatment Centers;
• For allogeneic cell therapy products, well-characterized cell banks may be scaled up with suspension systems using single-use bioreactors to meet clinical and commercial demand for the cell products;
• Cell-derived therapies include CAR-T, TCR-T, Dendritic, Natural Killer, TIL, Treg, monocytes, and macrophages;
• Tissue-derived therapies can be started from TIL, induced pluripotent, mesenchymal stem cells, hematopoietic stem cells, and other regenerative therapies.
• World-class Manufacturing Execution and Quality systems minimize manufacturing hiccups while streamlining efficiency enabling parallel batch processing and reducing manual data entry and review times by 50-70%. This enables the Quality Control (QC) Team to operate in direct conjunction with manufacturing for method transfer, optimization, qualification, and validation. Testing and analytical labs are directly adjacent to production for rapid and seamless CGMP testing;
• Core cell therapy analytical methods and highlights:
- qPCR, rapid micro methods, flow cytometry, ELISA, and automated cell counting.
- Incoming raw material, in-process and final product testing;
- Network of qualified contract testing laboratories to supplement in-house capabilities;
- Environmental, personnel and utility monitoring.
Our content about Cell Therapy:
White Paper: Seven Steps for Allogeneic Cell Therapy Success.
Webinar: Forward Engineering Cell Therapy Production Capabilities to Save Patient Lives.
