Rapid Technology Transfer for Large Scale Fermentation

A chemical manufacturer required manufacture of an enzyme at large scale in a whole cell catalyst spray dried, for production of a bulk industrial chemical. The customer’s current contract manufacturer’s availability changed, and their alternative supplier did not have the capacity or logistics to supply the enzyme. The challenge was to transfer the enzyme manufacturing technology process in the timeline and scale required to meet the customers manufacturing schedule and meet their stringent QA and QC requirements.

There was an initial meeting to discuss the feasibility of transferring the technical process, completing the logistical requirements pertaining to the manufacture of the enzyme and meeting the regulatory constraints, all in a timeline that would meet the customers compressed schedule. Once these parameters were agreed, including the product specification, yield and activity, a detailed project plan was developed to deliver product to the customer in 8 weeks. Although this product is the large-scale production of a whole cell catalyst; Biocatalysts Ltd can also produce isolated intracellular enzymes following cell breakage and downstream processing.

The first 18,000L fermentation was undertaken within 8 weeks and downstream processing and QC testing completed. Product was dispatched to the customer that met their specifications and regulatory requirements 6 weeks after the initial meeting. A routine supply agreement was then established to supply 36 fermentations a year. After initial transfer and supply was established, a project was undertaken by Biocatalysts to improve the process to optimise and maximise product yield and stability of the final product.

Benefits

• Rapid transfer of technical information
• Regulatory support
• Reliable supply of materials at large scale
• Project management to ensure key milestones hit
• Product optimisation