Dr D. Muruganand, vice-president, Marketing, Eppendorf India
The Biopharma industry is growing steadily at a significant pace and so are their investments in research and development. Investment in biologics like vaccine, biosimilars, novel biopharmaceuticals, cell and gene based therapeutic products are seeing a never before trend. The stakeholders, both scientists and investors are looking forward to shorter timeframes in getting the results and the product of interest launched in the market respectively. As these processes involve cell culture or microbial fermentation, the need for dedicated mini-bioreactor systems for process development and critical parameter optimizations in low volume ranges are certainly creating interest compared to the conventional fermenters and bioreactors. With time being very critical, the single use vessels are also gaining more attention over autoclavable formats among the Biopharma users.
From Conventional shake flasks to Parallel Bioreactors:
While initial bioprocess development involving microbial or cell culture involves several steps like cell line optimization, clone selection, screening for media and feed components along with other process conditions, conventional Shake flasks are still used for optimizing these early steps. Though widely used, Shake flask formats only allow identifying temperature, ambient gas mix and agitation rates but pose limitation upon reaching scalable levels with respect to the industry standard monitoring and control requirements. Critical process parameters like pH, dissolved oxygen (DO), gas flow rates and feed schedules of media components are beyond the capabilities of shake flask format. Moreover equipment used for screening or optimization in the earlier steps should mimic the physical and mechanical characteristics of production-scale reactors to the greatest degree possible, to ensure consistency throughout development phases. The parallel bioreactor system provides all essential features in a compact and comprehensive design with flexibility to optimize and understand parameters that influence growth kinetics, productivity, product quality and stability.
Parallel bioreactors over the Micro / Mini bioreactor systems:
Though micro and mini bioreactor systems address the basic needs of media selection and optimizations they still do not support when it comes to scalable proportions and concerns over unconventional formats are not uncommon. Lower volume by itself seems to limit for applications where the processes requirements are not flexible. Feed rates, sampling volumes to mention a few could be mandatory in these critical steps of characterization or optimization. Hence selection of an ideal system for lower volumes is no different from the standard volumes when it comes to the expectations of the process outcome.