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Manufacture Bioprocessing - Upstream & Downstream, Bioprocessing - Single Use Systems, Technology and Equipment, Standards & Regulation

Optimizing Manufacturing Strategies for mAbs

sponsored by Thermo Fisher Scientific

mAbs are an essential therapeutic modality – helping companies industry-wide to reach and treat patients. In this free-to-access eBook, you can explore the best approaches to equipment selection, unpack early scale-up strategies, and delve deep into the world of modular manufacturing.

Matthew Zustiak, Director of the Bioprocess Collaboration Center at Thermo Fisher Scientific, begins by walking through the steps for choosing best-in-class bioprocessing equipment. He says, “You must build your capacity from the start to meet your market estimation, and this, therefore, dictates the type of equipment (and size) that will be required. You also need to consider how many batches per year will be required, and ensure you have the appropriate profile of equipment to meet that demand.”

Kristina Pleitt, Senior Manager in the Bioprocessing Collaboration Center at Thermo Fisher Scientific, goes on to discuss the biggest barriers to scale-up and provides pertinent solutions for companies aiming to produce medicines for the masses. “One mistake that can creep into early R&D is to ignore incorporating short experiments to improve the manufacturability of the process,” she says. “By considering how the process will be performed in GMP, a few select experiments can provide insights on the design space and de-risk potential challenges at scale.”

Finally, Thermo Fisher’s Robert Hendrix, Kayla J. Spivey, and Levi M. Larsen outline how standardized modular manufacturing can make single-use an attractive option for drug developers.

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