As part of ongoing support of a pharmaceutical client’s new product submission, Kymanox assisted in the development of the Human Factors Engineering and Usability Engineering (HFE/UE) Report using the expertise from Kymanox Human Factors subject matter experts (SMEs) and device and design engineers to ensure FDA guidelines and requirements were met.
Challenge
Client did not have the in-house expertise to manage certain aspects of the project that were vital for a successful launch.
Solution
Kymanox developed a validation program and trained the client on how to manage the process independently going forward.
Results
Kymanox developed Precision Biosciences’ validation program from scratch and wrote all related procedures. The team also managed the implementation of this program including training and educating the client so they could independently manage it going forward.
A fully qualified GMP facility was released in less than 6 months from completion of construction. This was a one-year project with six months spent planning engineering and validation programs followed by execution of commissioning and qualifications.
“Calling it the Manufacturing Center for Advanced Therapeutics (MCAT), Precision touts the facility as ‘the first in-house current Good Manufacturing Process (cGMP)-compliant manufacturing facility in the United States dedicated to genome-edited, off-the-shelf chimeric antigen receptor (CAR) T cell therapy products.’” NCBioTech Press Release