CMO’s Cannot Produce SP2/0 Working Cell Bank: Cytovance® Identifies Problem and Successfully Produces WCB
Benefits of the Case:
A viable Working Cell Bank (WCB) that thaws with good viability and demonstrated logarithmic growth necessary for expansion
Further Characterization of Cell Line
Background and Challenge:
The client had purchased a Master Cell Bank that had been manufacturing in 1999.
The client is able to grow cells successfully in the R&D laboratory.
The client transferred vials of MCB to a well-known CMO to manufacture a WCB
The CMO failed several times to successfully manufacture a WCB
Poor viability and no growth
Cytovance® to perform tech transfer utilizing data from Client R&D and CMO
Cytovance® to manufacture Engineering lot using tech transfer parameters from R&D to demonstrate transfer
Engineering Run data:
The MCB thawed with a good viability and had adequate growth to scale-up to achieve cell numbers to lay down 350 vial WCB
Post Freeze Testing of the engineering run showed good viability at thaw, but viability declined and growth was not achieved.
The beginning, middle, and end of bank was tested with the same results
Filling process run at room temperature and cells were exposed to DMSO for 60 minutes
Cryogenic freeze profile utilized forced nucleation
Using MCB utilize Manufacturing and Process Development technicians to study DMSO hold times
Using MCB utilize Manufacturing and Process Development technicians to study room temperature versus cold process temperatures
Using MCB utilize Manufacturing and Process Development technicians to study Cryogenic freeze profile (1°per minute, < 1° per minute)
Value for Client:
A GMP run was commenced with the new freeze profile and after Post Freeze Testing of the newly manufactured WBC the bank thawed with good viability and achieved the required growth rate
The clients may now continue production and get their product into clinical trials