Understand Bioprocess Variation To Ensure Technology Transfer Success

By Nick Hutchinson, Parker Bioscience Filtration

The scale-up and transfer of manufacturing processes is 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.