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16th October 2015

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Biocatalysis for the Improved Manufacture of an Active Pharmaceutical Ingredient (API)

Reduction of carbon footprints and identification of “green”, sustainable alternatives  to fossil fuels are drivers across many industries, including speciality chemical and pharmaceutical manufacture. Although biocatalysis can facilitate the transition away from fossil fuels, few chemical manufacturers have experience with enzymes, and the application of economically viable industrial manufacturing processes using enzymes at commercial scale is a considerable challenge. Through an Innovate UK funded project, Biocatalysts are working with two UK SMEs, Charnwood Technical Consulting and CatScI, to enable Aesica to realise the potential of biocatalysis as a differentiator.

Background
A consortium led by Aesica, involving Biocatalysts, CatScI and Charnwood Technical Consulting was formed with the aim of establishing an industrial biotechnology process to improve the sustainability of the manufacture of an active pharmaceutical ingredient, and to deliver a manufacturing process that could compete with alternative low cost economy manufacturers. The combination of a high value chemical manufacturing end user, an industrial biocatalyst developer and manufacturer and two experts in both technical and industrial use of catalysis provided the perfect combination of skills to ensure the outlined technical challenge could be tackled in a demanding 9 month timeline and hence a ~£200k grant was awarded through the Innovate UK High Value Chemical Manufacturing 2 competition (2013).

The Project
The various roles of the consortium members were:

  • Charnwood Technical Consulting –  Advise on the technical aspects of process design, quality and regulations.
  • CatScI – Perform proof of concept studies to assess the feasibility of applying a novel biocatalytic route to production of an active pharmaceutical ingredient (API).
  • Biocatalysts –  Rapidly produce a range of novel enzymes using scalable manufacturing processes for CatScI to screen and for Aesica to test at pilot-scale.
  • Aesica –  Scale-up the process defined by CatScI, to assess the feasibility of the process at large-scale. Aesica were also the end user of the process.

Following the successful proof of concept studies, Biocatalysts created a panel of 6 lipases for screening against the target substrates. Once the activity of these were confirmed, scalable manufacturing processes and “Design for Manufacture” principles were applied to provide pilot scale volumes of those enzymes determined by CatScI as being effective for the required conversion. Design for Manufacture (DFM) is the underpinning strategy for production of enzymes at Biocatalysts. From the moment that the project undertakes its first inception meeting, through to producing multi-tonne amounts of enzyme, the DFM principles are employed. Basically, it is a forward thinking approach which ensures that at every stage of enzyme development, optimisation and scale-up we are always looking towards making life in routine production as straightforward as possible. This approach allowed for this stage of the project to be completed within three months.

The Outputs

  • The project delivered a biocatalytic route for production of an API within a 9 month period.
  • Biocatalysts developed a panel of 6 enzymes within a 3 month period.
  • Further advances are now being made to translate this research into an industrial process.

If you would like to explore the potential of enzymes and biocatalysis for your technical and commercial challenges, and don’t know where to start, please contact us to discuss the possibilities.