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In this second of three podcast interviews, Dr. Hallam, chief scientific officer at Sutro Biopharma, goes into some more detail about the protein expression system and describes a future GMP facility for the production therapeutic proteins and peptides. Batch sizes and yields are discussed, which for a cell-free system take on slightly different meaning; the cell extract used to produce the protein can be freeze-thawed and so effectively stockpiled. Once a sequence is known, the extract can be producing protein product 10 hours later, hence the systems potential robustness in a pandemic scenario. The new GMP facility, scheduled to open in 2012, will feature 200L fermenters for both extract and protein production at a scale that will take Sutro into Phase I and early Phase II studies. Dr. Hallam also delves into a product pipeline that is made up of Sutro's own candidates but also potential big pharma collaborative projects. The unique nature of the new process and intention for a GMP facility have led Sutro to initiate consultative discussions about regulatory requirements; early indications are positive, with quite some degree of excitement. Posted Nov. 2011.
Podcast 1 on the cell-free protein expression system
Related article on industrializing design, development, and manufacturing of therapeutic proteins
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