The Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing, has announced its participation in a consortium to develop an automated continuous biologics purification unit for more efficient manufacture of a wide range of biologic drugs.
This new unit will enable the industry to adapt more rapidly to changing market demands, giving economic as well as sustainable advantages.
The consortium’s participating organisations are Pall Europe Ltd, CPI, Allergan Biologics Ltd, Fujifilm, Diosynth Biotechnologies UK Ltd, Medimmune Ltd and GlaxoSmithKline, and the consortium is funded by £4.5 million from Innovate UK.
As biopharma moves to the business mainstream, the industry will increasingly need to find new ways to maintain competitiveness by ensuring affordability, quality and delivery performance.
Continuous processes have been proposed as a solution as they are scalable, offer higher productivity with reduced running times and materials usage, and require smaller footprint and less capital intense facilities. In addition, automated continuous bioprocesses minimise human intervention and, thus, the potential for errors.
This project brings together five leading biopharmaceutical companies with UK operations, process technology suppliers and CPI’s National Biologics Manufacturing Centre, part of the High Value Manufacturing Catapult, to develop an automated continuous biologics purification unit for more efficient manufacturing.
The new unit will consist of integrated, multiple operations running concurrently. All the lab work will be completed at the facilities of CPI using equipment provided by Pall and using feedstock from the manufacturers in the consortium.
“This project will integrate all downstream processing operations into one unit so that a range of biologics are purified and formulated in hours, compared with many days. The value brought to process development and preclinical studies will also be transcribed to clinical manufacturing scenarios,” said Rob Noel, Business Development Manager EU and ASIA, Pall.
“As the biologics industry moves to drive the cost of complex therapies down and increase productivity, continuous processing is becoming a key area of interest. Although other manufacturing sectors are already using continuous processing effectively, it is not being widely used in the biologics industry.”
“With the expertise assembled within this consortium, we believe a significant contribution will be made to the way the industry manufactures biologics,” said Mark Bustard, Business Development Director, Biologics, CPI.