Cell Therapy
Supporting unique autologous and allogeneic therapeutic development
Leading-Edge Cell Therapy Services for Cutting-Edge Treatments
Unmatched Expertise and State-of-the-Art Facilities for Cell Therapy Process Development, GMP Manufacturing, and Clinical Support
At KBI Biopharma, we are at the forefront of the rapidly-evolving field of cell therapy, providing a wide range of services to support the development of next-generation cell-based treatments.
Our team of experts has extensive experience in all aspects of cell therapy, from early-stage process development to clinical trial support and cGMP manufacturing. We combine our deep knowledge to deliver unmatched value to our customers.
Our cell therapy process development services are designed to help customers overcome the many technical challenges involved in developing and optimizing cell-based treatments. We work closely with our customers to design and execute experiments that will help them achieve their process goals, such as maximizing cell yield to meet lot size requirements, improving cell viability, and optimizing product quality. Our cGMP manufacturing services are equally comprehensive, with a focus on quality, consistency, and scalability. We use cutting-edge technologies to ensure that our clients' cell-based products meet all regulatory requirements and are manufactured to the highest standards.
- Extensive experience in process development for a wide range of cell types, including T cells, NK cells, and more
- Deep understanding of the regulatory landscape for cell therapy, including FDA and EMA requirements
In addition to our process development and manufacturing services, we also offer comprehensive clinical support for cell therapy trials. Our team of experts can provide a wide range of services, including therapeutic monitoring, safety assessments, and logistics support. We work closely with customers to develop customized solutions that meet their specific needs, ensuring that their clinical trials run smoothly and efficiently.
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Changing the Course of Healthcare for Challenging Disease Indications
Contract Development and Manufacturing Solutions
To Accelerate the Delivery of 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 2003. 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.
Cell Therapy Process Development
KBI’s Process Development capabilities allow us to translate basic operating procedures into robust, reproducible, scalable manufacturing processes to accelerate a client’s clinical development program.
- Six ISO 7 cGMP Manufacturing Suites
- Proven logistics and warehousing operations
- Extensive flow cytometry and analytical infrastructure
Development projects may be ‘stand alone’ or part of a fully integrated cGMP manufacturing project. KBI facilitates technology transfer from our customers. Our Development Lab processes runs per customer protocols.
Cell Therapy Analytical Development
KBI’s Analytical Development capabilities include three main areas:
- Product identification, quality, and purity
- Product activity and potency
- Product stability and safety
We work closely with customers to help them overcome the challenges involved in developing and optimizing cell-based treatments.
Cell Therapy GMP Manufacturing
KBI offers Ph I/II GMP manufacturing capabilities in ISO 5 BSC and ISO 7 clean rooms. Our cGMP cell culture facility offers six independent culture suites, a unidirectional flow of personnel and materials, and environmental monitoring to support quality manufacturing processes.
Cell Therapy Clinical Support
KBI provides patient sample collection and product delivery with validated shippers as well as regulatory support. We have experience successfully managing manufacturing materials with centralized receipt and supply of patient materials to facilities across North America.
Cell Therapy Clinical Trial Therapeutic Monitoring
At KBI our therapeutic monitoring programs are custom-tailored to the product & clinical indication leveraging multiple methods.
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