Protein nucleation and crystallisation on novel 3-D templates

人们对生物制药的结晶了解甚少，并且很少用于蛋白质的初级分离和纯化的商业过程。该提案描述了通过开发具有已知表面化学和地形的新型固体模板来控制非均相成核和晶体生长的蛋白质成核和结晶的基础研究。这些模板将提高蛋白质结晶/成核的成功率，从而提高对这两个过程的理解，并可能为工业生物结晶过程的发展奠定基础。该提案代表了生物制药制造的主要新下游机会的第一步，在产品分离和纯化方面提供了潜在的主要成本和生产力优势，以及晶体产品比传统产品/剂型提供的主要产品稳定性和输送优势。这一战略的最终成功将使英国工业在生物制药加工方面具有国际竞争优势。

The crystallisation of biopharmaceuticals is poorly understood and is a rarely used commercial process for the primary separation and purification of proteins. This proposal describes a fundamental investigation into the nucleation and crystallisation of proteins via the development of novel solid templates with known surface chemistry and topography for their controlled heterogeneous nucleation and crystal growth. These templates will enhance the success rates for protein crystallisation/ nucleation, allowing an improved understanding of both processes as well as potentially forming the basis for the development of industrial bio-crystallisation processes. This proposal represents the first step towards a major new downstream opportunity for biopharmaceutical manufacturing, providing potentially major cost and productivity benefits in product separation and purification, as well as the major product stability and delivery advantages offered by crystalline products over traditional product/dosage forms. The ultimate success of this strategy would give the UK industry an international competitive advantage in biopharmaceutical processing.