Cell & Gene Therapy
Cellular therapies are genuinely changing the course of health care for some of our most challenging disease indications. The biopharmaceutical industry needs contract development and manufacturing solutions to accelerate the delivery of these innovative products to patients.
KBI's Cell Therapy team, located in The Woodlands, TX, has managed a fully functional manufacturing facility supporting cell therapies and developing therapies under IND since 2001. Our team has substantial expertise and knowledge in cellular therapies' manufacturing, process development, and regulatory aspects, including maintaining solid relationships with the US FDA and Health Canada.
Our Cell and Gene Therapy Manufacturing
Ph I/II GMP manufacturing capabilities in ISO 5 BSC and ISO 7 cleanrooms
Our GMP cell culture facility offers three independent culture suites, a 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 primary science assays into robust, reproducible, scalable manufacturing processes to accelerate a client's clinical development program.
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
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