In 2014, Isomerase was approached by a succesful biotech company looking to outsource the scaling up of their proprietary process to deliver kilo scale quantities of product for further testing. This project was particularly challenging because:

  • The process had not previously been run at a scale above 100L
  • The material was required rapidly with limited time for process improvement

Our approach was to carry out process improvement in parallel with scaled production at multiple facilities up to 50,000L scale. During this project, we assisted our client with the following:

  • Preparation of a detailed Request for Proposal and distribution to a selected group of CMOs with follow-up calls and meetings
  • Assessment and prioritisation of the tender proposals both in terms of technical details and value for money
  • We worked closely with our client and the CMO to ensure a smooth technology transfer
  • We put skilled staff on site during the manufacturing campaign to ensure adherence to batch recipes and quality standards

The outcome was the successful and timely supply of kilograms of material at the right specification for further development.

If you would like to learn more about how we can help you develop and scale-up microbial processes to deliver kilo quantities of material you can contact us

 

scale up to 50000 litres

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