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Protein-Product Separation Technologies for Biocatalytic Reactions Utilized in Commercial API Manufacture

January 25, 2023

The ETC is seeking seeking information on scalable solutions that separate product from protein from typical biocatalytic reaction streams and are capable of operating with the following considerations: 
  • Compatible with aqueous / organic solvent mixtures
  • Can tolerate insoluble solids
  • Can tolerate enzyme loadings up to 50 wt% relative to starting material.
  • Aspirationally, the separation technology results in product with < 1 wt% residual protein and has > 90% product recovery
We are interested in both established technologies and novel approaches which could be adapted to conventional small-molecule manufacturing trains without significant facility modification. Ultimately, we seek approaches that maximize product recovery and purity, and enable efficient, robust application and development from kg to tonne production scales for API synthesis.
The efficient, scalable, protein-product separation remains a key challenge for the successful commercial implementation of biocatalysis. Many biocatalytic processes are performed in conventional chemical reactors using one or more unpurified, recombinantly produced enzymes (which contain both the desired enzyme and residual host cell proteins from the expression host). Existing protein-product separation strategies suffer from numerous challenges including volumetric inefficiency, poor protein rejection, and high product loss. Most approaches must be developed as fit-for-purpose solutions that are tuned for the specific chemistry, scale, and manufacturing infrastructure. They are often insufficiently robust and challenging to develop due to a lack of appropriate scale-down models. As a result, protein-product separation operations require significant engineering resources to develop, introduce substantial risk and process variability, and can negatively impact process productivity and yield.

Download the Request for Information and submit your response.

RFI ISSUED:  January 25, 2023

QUESTIONS on RFI DUE to ETC:  March 1, 2023

RFI RESPONSES DUE to ETC:  May 1, 2023

Q&A - Note see FAQ document for answers to common questions

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