High throughput protein stability analysis systems for biopharma

用于生物制药的高通量蛋白质稳定性分析系统

• 批准号: 830088
• 金额: $ 127.42万
• 依托单位: APPLIED PHOTOPHYSICS LIMITED
• 依托单位国家: 英国
• 项目类别: Innovation Loans
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=830088
• 关键词: throughput; protein; stability; analysis; systems

To ensure product safety and efficacy, protein therapeutic critical quality attributes must remain within tolerances for the duration of the shelf life of the product, as well as during transportation, storage and use. Consequently, development of and testing for long term stability of the protein drug product is a major focus of biotherapeutic development and formulation activities. Thermodynamic stability of the higher order structure of the protein is used as a proxy for longer term stability of the drug product, allowing many potential formulation conditions or variants of the drug product to be screened in a time period significantly shorter than the potential shelf life, greatly increasing the speed the drug can be developed and commercialised. This project is to develop a new high throughput technology for the screening of protein stability that requires very little sample and is able to be extensively automated. The target market will be biopharmaceutical development and formulation, allowing much higher numbers of drug candidate variants or formulation conditions to be screened earlier in the development cycle.

为确保产品安全性和有效性，蛋白质治疗关键质量属性必须在产品有效期内以及运输、储存和使用期间保持在公差范围内。因此，蛋白质药物产品的长期稳定性的开发和测试是生物制剂开发和配制活动的主要焦点。蛋白质的高级结构的热力学稳定性用作制剂的长期稳定性的代表，允许在显著短于潜在有效期的时间段内筛选许多潜在制剂条件或制剂变体，大大提高了药物的开发和商业化速度。该项目旨在开发一种新的高通量技术，用于筛选蛋白质稳定性，该技术需要很少的样品，并且能够广泛自动化。目标市场将是生物制药开发和配方，允许在开发周期的早期筛选更多的候选药物变体或配方条件。