Cell Therapy Manufacturing Process
Cellular therapies are truly changing the course of health care for some of our most challenging disease indications, and the biopharmaceutical industry needs contract development and manufacturing solutions to accelerate delivery of these innovative products to patients.
KBI’s Cell Therapy team, located in The Woodlands, TX, has been managing a fully functional manufacturing facility supporting cell therapies and have been developing therapies under IND since 2001. Our team has substantial expertise and knowledge in the manufacturing, process development and regulatory aspects of cellular therapies as well as maintain strong relationships with the US FDA and Health Canada.
KBI provides the following cell and gene therapy manufacturing services:
Ph I/II GMP manufacturing capabilities in ISO 5 BSC and ISO 7 clean rooms
Our GMP cell culture facility offers three independent culture suites, unidirectional flow of personnel and materials, and environmental monitoring to support quality manufacturing processes.
Cell Therapy Process Development
KBI’s Process Development capabilities allow us to translate basic science assays into robust, reproducible, scalable manufacturing processes to accelerate a client’s clinical development program.
Parallel processing of cell therapy products
Through stringent control of processes, materials and equipment, we can process numerous products for a single client’s project in parallel, thereby reducing cost and time required for a project.
Centralized receipt, manufacture, and supply of patient materials to facilities across North America.
The ability to develop and manufacture cellular therapeutics for clinical indications including autoimmunity, immunoncology, and regenerative medicine
Autologous & Allogeneic Cell Therapy
- Conventional T cells
- Regulatory T cells
- Dendritic cells
- B cells
- NK cells
- Stem cells
- Tumor cells
- Cell Lines
- Genetically engineered cells (CAR-T, TCR)
- Antigen-specific T cells
Learn more about we can help you with:
- Process Development
- Analytical Development
- GMP Manufacturing
- Clinical Cell Therapy Support
- Clinical Trial Therapeutic Monitoring