Protein nucleation and crystallisation on novel 3-D templates

生物制药的结晶过程知之甚少，是一种很少使用的初级分离和纯化蛋白质的商业过程。这项建议描述了通过开发具有已知表面化学和形貌的新型固体模板来控制蛋白质的异相成核和晶体生长来研究蛋白质的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，使人们能够更好地了解这两个过程，并有可能为工业生物结晶过程的开发奠定基础。这项提议代表着朝着生物制药制造的新的重要下游机会迈出的第一步，在产品分离和纯化方面提供了潜在的重大成本和生产率好处，以及晶体产品相对于传统产品/剂型提供的主要产品稳定性和交付优势。这一战略的最终成功将使英国制药行业在生物制药加工方面获得国际竞争优势。

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.