High throughput protein stability analysis systems for biopharma

为了确保产品的安全性和有效性，蛋白质治疗的关键质量属性必须在产品的保质期内以及在运输、储存和使用期间保持在容许范围内。因此，蛋白质药物产品的开发和长期稳定性测试是生物治疗开发和配方活动的主要重点。蛋白质高阶结构的热力学稳定性被用作药物产品长期稳定性的替代指标，使药物产品的许多潜在配方条件或变种能够在比潜在货架期短得多的时间内进行筛选，大大提高了药物开发和商业化的速度。该项目旨在开发一种新的高通量蛋白质稳定性筛选技术，该技术只需要很少的样本，并且能够广泛自动化。目标市场将是生物制药的开发和配方，允许在开发周期的早期筛选更多数量的候选药物变体或配方条件。

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.