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Reducing Commercial Risk for Industrial Biotech SMEs

15 May 2018

Industrial biotechnology companies can often suffer financial setbacks when transitioning products from the laboratory to commercial scale.

ERDF

Ultimately, this risk-mitigation expertise will increase the confidence of SMEs to invest in the area, and help build the North-East of England into an international hub for commercialising next generation chemical and biofuels manufacture.

In early 2017, the UK Catapult provided £358,000 to supplement the targeted investment of £538,000 from the ERDF.

A total budget of £896,000 was therefore secured to deliver the project’s aim of stimulating regional growth in the Industrial Biotechnology sector.

Construction took place throughout 2017, with £105,000 of the budget for improving infrastructure, while the remaining £791,000 was utilised to cover new research equipment and other capital costs.

New IBB Scale-Up Capability Programme Equipment

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Now installed, the cutting-edge capability will support clients with the expertise and knowledge of three dedicated full-time scientists who have commissioned and characterised the new equipment.

The key benefit of CPI’s equipment for SMEs and potential clients is the ability to perform upstream and downstream process development under scale-down conditions.

These conditions are designed to reflect the constraints of large-scale industrial operations without requiring the financial investment typically associated with full-scale evaluation In effect, this set up generates significantly more data relevant to scaled operation of a client’s process but at the laboratory scale cost.

Scale-up related issues can therefore be addressed early in the technology development cycle to facilitate rapid process development while minimising unnecessary costs. The equipment itself provides capabilities over three areas:

Upstream process development - the first step in the biorefining process, in which microbes/cells are grown and characterised. CPI’s equipment covers the scales between 1 millilitre and 1 litre, allowing growth of both aerobic and anaerobic microorganisms on a range of carbohydrate and C1 gas feedstocks. This new capability complements CPI’s existing ability to go from 1 millilitre to 10,000 litres.

Downstream process development - the second step in the biorefining process, in which the product is isolated and purified. After feedstock, this process stage is often the next most expensive contributor to the overall process cost and includes unit operations such as centrifugation, membrane fractionation, chromatographic separation, and solvent extraction, typical unit operations characteristic of large-scale, industrial processes.

Analytics - the analyses of key processes to provide vital data for continual improvements. These include the measurement of gas compositions by mass spectrometry and the characterisation of feedstock, fermentation and downstream process samples.

With these assets in place and Phase 1 of the IBB Scale-Up project complete, Phase 2 began at the beginning of 2018.

This involves the creation of written procedures and safety risk assessments for each item of equipment and the rigorous training of CPI staff in their operation.

The CPI team is currently validating scale-down models, defining the critical operational parameters and the operating ranges relevant to equivalent large scale assets for each of the new equipment.

CPI has appointed Stephen Wright as new downstream process lead scientist who will work with existing project teams to apply these new capabilities to current and future projects in the industrial biotechnology and biorefining business unit.

Historically, products were progressed to large-scale without a second thought and they failed either technically or commercially,” says Santhana Krishnan, CPI Project Manager, “but with the advent of computational modelling and powerful simulation technologies, the industry is starting to embrace improved ways to address old problems.

SMEs put their trust in CPI so it is vital we provide the best available state-of-the-art services to them.”

CPI understands the risks involved in developing processes from initial stages to commercial scale. Those involved in the IBB Scale-Up project are, therefore, immensely proud of its recent milestone. The project has been an incredible effort requiring coordination across several scientific and engineering teams, as well as numerous equipment manufacturers and suppliers to ensure the required equipment specifications and installation requirements were met.

As the project moves forward beyond Phase 2 later this year, these important efforts will become validated as SMEs and other start-ups partner with CPI to trial their biotechnology processes under scale-down conditions generating accurate data quickly and cost effectively.