GMP & GTP
Manufacturing
From Draw-to-Thaw™: Optimized
cGMP & GTP Manufacturing for Advanced Therapies
Service
Description
At CCS, we provide end-to-end cGMP manufacturing solutions tailored for advanced cell therapy developers — ensuring regulatory compliance, scalability, and high-quality production. Our expertise spans both autologous and allogeneic (off-the-shelf) therapies, enabling seamless transitions from process development to commercialization. Whether scaling out or scaling up, our focus remains on efficient, cost-effective manufacturing.
As a non-profit organization, CCS delivers exceptional value while maintaining strict GMP and regulatory standards. We specialize in manufacturing optimization through process closure and automation, and our unique Draw-to-Thaw™ model integrates cell sourcing, processing, and cryopreservation for a true vein-to-vein solution.
From tech transfer and advanced bioprocessing to rigorous quality control, we accelerate the path from development to market for cell therapy products.
Why
Choose us?
Proven efficiencies for minimally manipulated products
Draw-to-Thaw™ support under one roof
Cost-effective manufacturing for early phases
GTP Manufacturing
Our team utilizes over 500 sq ft of lab space for the processing of intermediate GMP products and clinical apheresis for infusion, in compliance with CFR 1271, ensuring the highest quality for irreplaceable biomaterials. This includes bone marrow processing, mononuclear cell enrichment, fill/finish of final drug products, and cryopreservation of apheresis material.
Quality Control Labs
Labs adjacent to GMP manufacturing suits support the conduct of flow cytometry, cell analysis, and release testing of manufactured products.