Square Pegs In Round Holes: Understanding Bioprocess Variation Ensures Facility Fit During Technology Transfer
By Nick Hutchinson, Parker Domnick Hunter
The scale-up and transfer of manufacturing processe is s common during the lifecycle of biopharmaceutical molecules. A lack of understanding of process variations can lead to poor process performance and even failures during such transfers.
During R&D phases only small quantities of biopharmaceutical product are needed but the requirements increase as the product enters clinical trials. Non-GMP pilot plant studies can be used to assess how the process will perform at larger scales and mitigate the risk of process failures during cGMP manufacture. Subsequent increases in cGMP production-scale are likely to be required as the molecule progresses through clinical trials and into commercial manufacture.
Increases in scale may involve transferring products between a sponsor’s manufacturing sites while a significant proportion will choose to transfer the process to a contract manufacturing organization (CMO). Additional transfers will be required should the product sponsor change their CMO or bring the process back in-house which can happen depending on their experiences and changes in manufacturing strategy.