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Case Study

Reducing costs in industrial applications

BioMOD is an Advanced Manufacturing Supply Chain Initiative project, funded by BIS with a range of collaborative partners investigating the SUT systems for bioprocessing in industrial biotechnology

The project aims to understand what advantages SUT can bring and address the challenges facing the UK bio-processing sector: high capital costs, scaleability issues, lack of flexible manufacturing capacity, no reactor standardisation and inherent commercial risks associated with single, large scale production vessels. BioMOD will look to develop not only the SUT to address the current limitations but will also look to evaluate the use of alternative recombinant hosts in industrial biotechnology.

The biopharmaceutical industry is heavily utilising single use technologies (SUT) and many facilities can now be found with little or no traditional stainless steel equipment, however, not all of the advantages of SUT are directly transferable to industrial biotechnology for a number of technical reasons of which the most profound is the limitation on oxygen transfer rate.

The plant capability characterisation to understand, compare and contrast stainless steel systems and the SUT system is underway and the area has been refurbished and set up for use as a “flexible” environment for bio processing. The University of Bath have been provided with the required data to begin building their fermenter and SUT models. The team have completed scale down studies to replicate large fermenter and SUT characteristics at scale in the 10/20L systems.

BioMod has progressed with aerobic and anaerobic fermentations in the 2nd generation SUT 1000L bags. The continuous improvement of the SUT bag for increased performance is underway in partnership with BioProcess Engineering Services and the University of Bath. One particular highlight has been the successful performance of the SUT system for the production of lactic acid using lactococcus lactis. Scale-down model of the current bag performance has been completed and now in collaboration with GlaxoSmithKline the team is working to transfer their process into the SUT system. The project has a very robust SUT unit which has been operated for periods of 2 weeks at maximum operating conditions without any degradation or loss of bag integrity.

The BioMod project will use the following technologies

Single use technology for ease of construction and cost-effectiveness of operation

  • The withdrawal of process control instrumentation from the vessel itself, allowing both high integrity operation and control, but without dispensing of the robustness or utility of the instrumentation
  • Small unit size, allowing scale up by multiplication of lower-cost units and giving easily reproducible process conditions based on small scale pilot work
  • The potential need to monitor only a few of the multiple vessels, as monitoring and control of one of a number of units can be used as an indicator of the integrity of operation of similar parallel units.
  • The linking of single use vessels together will lead to the development of continuous processing based on low cost and easily controlled sections
  • Simple operation of small scale modules, and the ready reproduction of this via the multiplication of low cost vessels
  • Limited or no utility requirements for each module, rather than centrally serviced large reactors with multiple capability and multiple service requirements
  • Units can be used for different growth stages and conditions, with no need to research the effects of translating the process onto a larger vessel with concomitant uncertainty in mixing and mass transport effects
  • Greater control over the ability to mix and match vessels for different process and product needs
  • The creation of a platform technology that allows greater variation in processes and products at far lower cost than previously available
  • Can provide the “proof of principle” at a sufficiently realistic scale to underpin the development of larger scale engineering designs and hence de-risk main production plant construction
  • Can provide a whole system of working from the host strain (vector) to the units required for continuous fermentation of that strain.

Partners

CPI

The Centre for Process Innovation (CPI) is a UK-based technology innovation centre and part of the High Value Manufacturing Catapult. We use applied knowledge in science and engineering combined with state of the art facilities to enable our clients to develop, prove, prototype and scale up the next generation of products and processes.

CPI lead the BioMOD project and will develop the BioMODule through process development and the translation of traditional processing into Single Use Technology (SUT). This should lead to an understanding of the capabilities and limitations of this technology in Industrial Biotechnology.

GSK

GSK is a science-led global healthcare company, carrying out research and development into a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.

GSK will provide the process to be developed in the BioMODule.

Bioprocess Engineering Solutions (BPES)

BioProcess Engineering Services Ltd (BPES) was founded in 1996 and provides Specialist Equipment and Maintenance Services. They offer a comprehensive maintenance and calibration service to their customers through a team of experienced engineers.

BPES will develop a low cost control system to bolt onto the BioMODule system for process control and data logging.

Offshore Renewable Energy (ORE)

The Offshore Renewable Energy (ORE) Catapult is the UK’s flagship technology innovation and research centre for offshore wind, wave and tidal energy.

ORE Catapult will carry out LCA study to help define the process economics of using the BioMODule in IB.

University of Bath

The University of Bath is a leading UK university with an international reputation for teaching and research excellence.

Their role in the BioMOD project will be to will carry out process modelling and CFD modelling.

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