Miniaturization of Bioprocess Unit Operations - Accelerating Bioprocess Development
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Large scale bioproduction process development involves a large number of individual processes and potential variables, and is generally more labor-intensive, time-consuming and expensive than its non-biological counterpart. High throughput techniques have been developed to mimic all the relevant processes used in the biopharmaceutical industry, allowing rapid and comprehensive automated characterization of proposed processes prior to pilot scale realization.
For biological manufacturing processes to be commercially viable, the development of both upstream and downstream processing must be accelerated and process analytics improved. This reduces the time and cost factors involved in the design of robust bioprocessing protocols, and the time-to-market for new products, offering better returns on research and development investments prior to patent expiry. Biological products are especially challenging for early phase process design, due to the large numbers of variables and complex processing requirements, and a variety of strategies are necessary to achieve rapid bioprocess optimization.
Miniaturization of bioprocess unit operations to the microliter scale is a cost-effective method of process optimization, reducing material, equipment and time requirements for development. This helps to minimize the number of expensive large-scale trials required, making it economically viable to conduct these trials far earlier in the product development program. All aspects of downstream processing, which can account for over 85 % of the total production costs, have been studied, focusing on rapid optimized process development for industrial scale-up, and developing high throughput techniques to mimic all the individual processes used. These miniaturized models enable rapid and comprehensive automated characterization of proposed processes prior to pilot scale realization.
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