28th October 2015

Transfer, Scale-up and Routine Manufacture of a Customers Enzyme &/or Protein

A biocatalyst was developed with a Contract Research Organisation who did not have sufficient capacity or logistics to supply the enzyme on a routine basis. The challenge was to improve the enzyme production process and scale-up production to meet the customer’s annual enzyme requirements. The final product required Halal, Kosher and food-grade certification.

Application: The customer had developed a novel biocatalytic route for synthesis of a high value flavour compound.

Customer Challenge: The biocatalyst was initially developed for the customer by a Contract Research Organisation who did not have sufficient capacity or logistics to supply this enzyme on a routine basis. The challenge was to improve the enzyme production process and scale-up production to meet the customer’s annual enzyme requirements. The final product required Halal, Kosher and food-grade certification.

Approach: The existing expression system (Pichia pastoris) and enzyme production methodology were reviewed against our best-in-class production methodologies (applying “Design for Manufacture” principles). The redesigned fermentation and original fermentation were performed in parallel at small-scale (3 L) to confirm acceptability of the new process – the production level was improved, and the product performed exactly as the original biocatalyst. The production was then scaled-up to routine production and validated in a series of 3 production runs (all yielding usable product for the customer). A routine supply agreement was then agreed for exclusive long term production of this bespoke biocatalyst.

Timescales:

• Process redesign and confirmation – 5 weeks
• Process scale-up – 1 week
• Customer application trials – 2 weeks
• 3 validation batches – 6 weeks
• Routine enzyme production – within 6 months of project start date
  

Benefits:

• Reliable supply of material at required scale
• Large-scale material of higher purity than small-scale, resulting in customer process improvement
• Exclusive product providing market differentiation