Quality and validation help for cell and gene therapy developers moving toward commercial manufacturing. Processes are often patient-specific, and FDA guidance is still changing.
Many cell and gene therapies are made one patient at a time. Validation approaches built for large batches often do not fit.
With an autologous therapy, the cells that leave a patient have to come back to the same patient. The quality system has to prove that happened, every time.
FDA guidance for these products is still changing. We keep track of it so your procedures do not fall behind.
Validation and quality system work as a program moves from clinical to commercial manufacturing.
A biotech is moving from clinical to commercial manufacturing. It needs a validation lead who has worked in biologics GMP production before.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
What do you make, what systems are involved, and what is the problem? We will tell you how we would approach it.