Ultra scale-down

Ultra scale-down aims at creating full-scale process conditions at the laboratory scale using millilitre quantities of material. This enables rapid development of robust manufacturing routes.

Bringing biomanufacturing insights to the lab

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What is ultra scale-down?
What are the key advantages of ultra scale-down?
How can ultra scale-down be applied?
Ultra scale-down devices and methodologies developed at UCL
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What is ultra scale-down?

The Ultra Scale-Down (USD) approach pioneered at University College London facilitates the establishment of the most cost-effective and scalable biomanufacturing routes, addressing the need for robust, low-cost initial studies in early stage process development.

Ultra scale-down aims at creating full-scale process conditions at the laboratory scale. It is based on the analysis and understanding of the unit operation as a whole (e.g. centrifugal clarification) and considers not just the conditions in the full-scale equipment but also the impact of material transfer during biomanufacturing through pumps and valves (i.e. the process material passes through regions of high shear stress). Ultra scale-down tools and methods developed at UCL allow manufacturing research at an early stage of product development using millilitre quantities of precious material, providing rapid insight of the effect of the engineering environment on process materials and into the performance of full-scale processes. This enables bioprocess engineers and process scientists to develop and assess manufacturing routes early in development.

Ultra scale-down tools and methods developed at UCL allow manufacturing research at an early stage of product development using millilitre quantities of precious material, providing rapid insight of the effect of the engineering environment on process materials and into the performance of full-scale processes. This enables bioprocess engineers and process scientists to develop and assess manufacturing routes early in development.

What are the key advantages of ultra scale-down?

Benefits of using USD technologies for bioprocess development and biomanufacturing include:

Prepare material at small scale that is representative of the full manufacturing scale
Gain insights into how the manufacturing environment affect process material
Speed-up process development, allowing for timely project (go, no-go) decisions;
De-risk process development
Gain process understanding earlier than traditionally possible and develop robust and cost effective biomanufacturing; and
Ensure robust technology transfer across scales.

Example application of ultra scale-down

Assessing the manufacturability of cell lines for the production of monoclonal antibodies (Mabs), antibody fragments (Fabs) or other modalities of antibody-based therapies (e.g. diabodies, nanobodies, antibody drug conjugates)
Evaluating the impact of cell culture conditions on the properties of the cell culture harvest and its performance during downstream processing
Determining the clarification performance of cell culture harvests
Identify impurities and determine impurity level post-centrifugation which may affect filter capacities and chromatography column re-use
Predict large scale centrifuge performance (% clarification, turbidity level)
Predict the impact of broth conditioning (e.g. flocculation) on centrifuge performance
Perform shear studies and determine impact of shear on cells, flocs, crystals and assess products (e.g. cells or cell markers, macromolecules such as antibodies or other proteins and enzymes etc)

Ultra scale-down devices and methodologies developed at UCL

The USD platform is a combination of specialized devices and experimental approaches which reduces the process material requirement for bioprocess research and development from the traditional tens or hundreds of litres at pilot-scale to the millilitre-scale. This allows users to gain Biomanufacturing insights while working in the lab (as opposed to a pilot plant or manufacturing facility).

Ultra scale-down rotating disc device (kompAs)
Ultra scale-down centrifugation method
Ultra scale-down filtration method for depth filtration and normal flow membrane filtration
Ultra scale-down membrane device (for crossflow filtration)
Ultra scale-down formulation device