![]() Resupply batches can be made very rapidly as raw materials and consumables will be in stock. As your manufacturing partner, we will assume responsibility for having backup materials for platform runs. We employ single-use technologies for upstream and downstream process development and scale-up of mammalian cell culture-based monoclonal antibodies, leveraging process closure analysis.Īll consumables are available in the onsite warehouse with resupply scheduled with the vendors. Our high-throughput manufacturing facility is scaled to multiple 2,000L bioreactors with an additional downstream suites. Scale Out cGMP production of monoclonal antibodies In order to avoid surprises during scale-up, we use the same analytical equipment and process equipment through the entire process The workflow and conditions can then effectively be optimized during process development to get you earlier access to monoclonal antibody cGMP manufacturing. This provides rapid insights during the discovery phase, to assist you in the identification suitable candidates with high antigen reactivity and the desired functionality. Our starting-point and focus – from clinical development through cGMP production and commercialization – is to minimize the host of hazard pathways over the mAb therapeutic lifecycle, thereby minimizing risks to timeline, quality, development, regulatory and the business.Įarly on, multi-well plates and micro bioreactors are used to screen cell lines to provide visual evidence of monoclonality in an environment that is very close to that of the production bioreactor. FUJIFILM Diosynth Biotechnologies offers a novel risk-minimizing approach to mAb production, designed from the ground up to deliver a dependable and efficient supply of monoclonal antibodies.
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