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. Development projects may be ‘stand alone’ or part of a fully integrated GMP manufacturing project. KBI facilitates technology transfer from our clients. Our Development Lab processes runs per client protocols.

Optimization of Process for the purpose of maximizing quality, scalability, and reproducibility including:

• Cell culture configuration
• Media optimization
• Growth factor feeding strategies
• Monitoring and control of cell culture metabolites
• Passage, Expansion
• Cryopreservation

Process Development can be tailored to client needs, including but not limited to:

• Transition from open culture system to functionally closed system
• Scale out or scale up to meet dosing requirements
• Capacity evaluation to determine appropriateness of parallel processing
• Product comparability and Stability studies
• Cryopreservation and Dose Delivery mechanisms development
• Transition to a Phase I/II compliant manufacturing process