View along a long row of automated bioreactor vessels with tubing, with a scientist in a blue lab coat working in the background

Case studies

Continuous biologics processing

Creating an integrated solution for continuous biologics manufacturing

Case studies

Continuous biologics processing

Creating an integrated solution for continuous biologics manufacturing

Case studies

Continuous biologics processing

Creating an integrated solution for continuous biologics manufacturing

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 Good Manufacturing 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

Rows of clear capped glass vials on a stainless steel filling line, in a blue tone

The challenge

Success in this project required a multidisciplinary approach, scientists, control & software engineers needed to work together to develop an integrated solution which was fit for purpose. This involved numerous workshops between consortium members to identify and agree the best approaches and necessary compromises.

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.

Achievements

Inputs

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.

Outputs

Conversion of established batch processes to continuous.
Expertise in developing suitable control strategies for flexible continuous manufacturing.
Technical knowledge around the challenges of implementing PAT 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.

Outcomes

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.