Continuous integrated biologics manufacturing
Continuous manufacturing offers the potential for higher efficiencies, reduction in cost and improved product quality over batch processes currently implemented within biomanufacturing. However, the adoption of continuous manufacturing has been slow due to technical challenges and concerns over operating within in a GoodManufacturing Practise (GMP) environment.
A range of ‘off the shelf’ continuous unit operations are available, but a technology gap exists around their integration into a complete solution. As well as limited supporting data to help companies fully assess the likely technical risks.
This IUK funded project brings together a number of technology providers and biopharmaceutical companies with an interest in continuous manufacturing and is focused on three key deliverables:
To develop a flexible automated biologics downstream platform, consisting of multiple unit operations that can be rapidly reconfigured for manufacturing different products
To adapt up to 3 established batch process to run on the continuous system and evaluate process performance and product quality
To demonstrate one of the transferred processes at a clinically relevant scale
- Requirement for a flexible control solution designed specifically to address the unique challenges of biomanufacturing
- 3 established batch processes
- Experience multidisciplinary resource both within CPI and across the partners
- Experience in delivery of cross technology projects
- Project management and business support services for publicly funded R&D projects
- Conversion of established batch processes to continuous
- Expertise in developing suitable control strategies for flexible continuous manufacturing
- Technical knowledge around the challenges of implementingPAT approaches on a continuous process
- Setup of a dedicated continuous processing laboratory
Increased cross disciplinary knowledge within internal and external technical teams
Economic evaluation of batch vs continuous
- Demonstration of functional prototype control solution for continuous biomanufacturing
- Practical expertise in moving batch processes to continuous
- Understanding of the critical path required to implement a commercial solution
- Data to support the development of a cost model
- Exemplification of collaborative project approach which would be expanded to include additional unit operations
How CPI helped
CPI was approached by industrial partners to be the key technical delivery provider for this project. The consortium leverage the unique capabilities at CPI to enable the rapid development of a prototype integrated system, sited in a dedicated laboratory. The system was then used to explore the practical challenges of converting established batch processes to continuous. Some of the starting materials were provided direct from industrial partners but some were manufactured on site using CPI’s large scale cell culture experience and facilities.
CPI played a key role in this project through the use of their state of the art facilities and expert knowledge.Learning from the project will help accelerate the implementation of continuous manufacturing approaches within biomanufacturing. The output from this project gives a solid platform on which to develop an initial commercial solution or support follow on projects exploring how advanced process control strategies could be incorporated to enable the full potential of a continuous manufacturing to be accessed.
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