How do we ensure the consistent quality of the product?
Benchtop and pilot scale experiments can be used to demonstrate the reproducibility of the biological process. Additionally, due to their smaller size, several bioreactors can be run in parallel to check whether the data produced is consistent. This stage is fundamental in verifying the robustness of the process, which is a crucial requirement when adhering to Good Manufacturing Practices (GMP).
At this stage, numerous batches must be run to demonstrate reproducible and consistent results in yield, product quality, and other critical characteristics under defined operating conditions. Reproducible processes at the pilot scale increase confidence for the industrial scale and are particularly relevant for regulatory submission.
Consistency, on the other hand, refers to the ability of the bioprocess to generate a product of uniform quality. On a pilot scale, the quality of the product is monitored throughout batches to ensure that parameters such as purity and potency remain constant. This is challenging to the inherent variability of biological systems, but by using strict control and parameters and consistent substrates, this variability can be kept to a minimum.
The BioXplorer, especially the BioXplorer 5000, is an excellent platform for scale-up processes. This model can operate at regular or high pressure and up to 5 L volumes. This facilitates a comprehensive understanding of critical processes that can be affected during scaling-up, such as energy and mass transfer at a larger scale. Moreover, it enables the exploration of oxygen and nutrient distribution dynamics, proving its worth as a versatile tool for optimization.