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Pharma Services : Case Study

The following example illustrates how Codexis biocatalysts ClosecloseBiocatalyst or Biological CatalystA catalyst derived from a living organism. Enzymes and fermentation strains are common biocatalysts. Biocatalysts significantly speed chemical reactions.can improve chemical manufacturing processes by reducing manufacturing time, cost, and waste.

The Challenge: Process Inefficiency

Current production of a high-volume pharmaceutical compound requires use of large amounts of a hazardous, selective reagent ClosecloseReagentA chemical substance that is used to start a reaction in combination with some other substanceto enable a critical chemical chiral ClosecloseChiralA chiral molecule is asymmetric, it cannot be superimposed on its mirror image. Many chemicals important to life are chiral. The US FDA requires that the two mirror image forms (‘enantiomers’) of a chiral compound be treated as different products that must be tested separately. Consequently, there has been extensive research into developing methods for making one or the other of the enantiomers – in other words, making the molecule chirally pure.reduction step. The use of high volumes of reagent also generates a large amount of waste that is tedious and time consuming to remove.

After extensive searching by previous researchers, an enzyme ClosecloseEnzymeProteins that act as catalysts, or biocatalysts, in living organisms.from nature was discovered that could perform the desired reaction. However, the enzyme was difficult to purify, produced less than ideal chiral purity, and was unable to perform using standard, inexpensive solvents.

The Solution: An Enzyme That Fits

Codexis identified a starting enzyme with activity from its collection of proprietary enzyme variants, but this variant still needed 2000x improvement in activity. Using its proprietary technology Codexis evolved an enzyme for activity, stability, and solvent tolerance. The resulting ThoroughBred biocatalyst meets commercially defined performance targets, and was developed in less than six months.

The Outcome: Lower Cost, Higher Quality, Less Waste

  • Raw material differentials: The Codexis biocatalytic process significantly reduces the raw material cost by obviating the need for expensive reducing agents ClosecloseReducing AgentA reagent in a chemical reaction that reduces (donates electrons) to another molecule.and solvents.
  • Manufacturing differentials: The Codexis process should be as simple to operate as the current process, carry a similar conversion cost, and offer potential time and cost savings due to simplified waste removal work up.
  • Quality advantage: Perfect enantioselectivity!
  • Green chemistry ClosecloseGreen ChemistryDesign of chemical products and processes that reduce or eliminate the use and generation of hazardous substancesadvantage: Using the current process, the reducing agent ClosecloseReducing AgentA reagent in a chemical reaction that reduces (donates electrons) to another molecule.produces as much waste as the desired product. In contrast, the Codexis biocatalytic process results in only 3-5 % waste.