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Polymer Materials for Cryogenic Storage and Distribution of Biologics

Project description

A really cool idea boosts the safety and efficacy of therapies on the move

Until recently, the transportation of sensitive pharmaceuticals along the supply chain from production to patient required relatively straightforward refrigeration technology. As therapies have gone from simple chemical molecules to protein macromolecules to living cells, the cold chain has had to adapt. Most biologics must be cryopreserved and, as anyone who has ever frozen and thawed a steak can appreciate, it is not an easy task to keep cells in tip-top shape during that process. Currently available technologies use organic solvents as cryoprotectants which are not perfect. The EU-funded ICE_PACK project is developing biomimetic polymeric cryoprotectants that will stabilise membranes and protect proteins from damage, significantly reducing the cost of therapeutics while enhancing their safety, efficacy and accessibility.

Objective

Ten years ago small molecules were the drugs of choice for most diseases. This situation has dramatically changed such that in 2017, 4 in 5 of the best-selling drugs were proteins, delivering major healthcare benefits from cancer to infectious disease. Cell-based therapies are also emerging, with the promise of making the incurable, curable (especially in oncology). However, the use of these ‘biologics’ has accelerated beyond the currently available technologies to stabilize these therapeutics against the environmental stresses imposed by the pharmaceutical cold chain. 75 % of current biologics must be cryopreserved to ensure they reach the patient in a functional format, requiring the addition of cryoprotectants (organic solvents) which are toxic, do not enable full post-thaw recovery, are complex to remove, do not stabilize cell membranes efficiently, lead to batch-to-batch post-thaw variabilities in function and cause toxic plasticizers to leach from transport bags.

ICE_PACK will develop unprecedented macro-and supra-molecular biomaterials to transform the biologic cold chain with long term impact by making these therapies more effective, cheaper, safer and more widely available.

We will synthesize polymeric cryoprotectants, inspired by Nature’s macromolecular ice modulators, capable of inducing ice nucleation, stabilising cell membranes and protecting proteins from denaturation, and apply these to cryopreserve real therapeutics. An integrated approach will be taken whereby ice nucleation and growth control will be studied in parallel to investigating the biochemical and molecular biology impact of cold stresses. Major fundamental scientific advances will also emerge, linking macromolecular structure to ice nucleation and to biochemical pathways of cold tolerance and stress.
The long term outcomes of this ground breaking ERC project will be the transformation of cryopreservation strategies, suitable for 21st Century biologic medicines.

Host institution

UNIVERSITY OF WARWICK
Net EU contribution
€ 1 999 863,75
Address
KIRBY CORNER ROAD UNIVERSITY HOUSE
CV4 8UW COVENTRY
United Kingdom

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Region
West Midlands (England) West Midlands Coventry
Activity type
Higher or Secondary Education Establishments
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Total cost
€ 1 999 863,75

Beneficiaries (1)