Univercells provides perfusion-based, small footprint, high density upstream manufacturing. Jacquemart outlined the specifics of the manufacturing process concept. A huge benefit of this continuous, small footprint manufacturing concept is that it would enable manufacturing in or near smaller emerging markets at costs that enable a sustainable economic model. The facility capital investment is estimated to be less than $25 million all-in for a mAb production capacity of up to 500 kilograms per year with cost of goods on the order of $50 per gram. By incorporating improved productivity in each unit operation, smaller facilities are enabled. To achieve this, the focus will be to combine upstream and downstream processing in one small footprint. The goal of the collaboration is to create a continuous, automated, small footprint manufacturing facility. Jacquemart then presented a collaborative project in development with Univercells. Achieving these goals requires a large increase in productivity and much-simplified single-use architecture for purification.ĭr. This permits faster turnaround and accommodates a wider range of scales and products for any given time period. To meaningfully decrease total cost and create the most efficient process, companies must significantly reduce the physical scale of manufacturing facilities and enable greater flexibility. Jacquemart begins by talking about the goal of creating a more affordable purification strategy and how the Natrix approach incorporates a holistic vision of the entire manufacturing process. Creating a more affordable purification strategy This strategy envisions the use of a unique Protein A membrane for which Natrix recently signed collaboration agreements with Merck & Co. One very interesting talk, given by Renaud Jacquemart, PhD Principal Scientist, Director Vaccines Process Sciences, was titled “Enabling Manufacturing Of Affordable Biologics Through The Use Of A Protein A Membrane In A Single-Use Purification Strategy ” and focused on the application of a fully single-use chromatography purification process in place of resins. In particular, there were several talks about optimizing the downstream purification process. Affordable Biologic Downstream Purification with Single-Use Protein A MembraneĪt this year’s Boston Biotech Week there were many exciting talks on downstream purification and associated new technologies.
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