Historically a single lead molecule would enter cell line development to progress towards final cell line selection and the upstream & downstream bioprocesses. As biotherapeutic molecular formats have evolved it’s increasingly important to identify & characterise the risks associated with molecule design and the potential impact of these risks during the manufacturing process. At GSK we have deployed a developability screen prior to cell line selection which assess typical industry standard molecule developability targets such as purity, target engagement and charge species heterogeneity.<br/><br/>Data presented is taken from a spectrum of analytical techniques assessing a number of lead molecules early in the drug development process ensuring only molecules with acceptable purity & target engagement profiles enter into cell line development. With the rise of high throughput cell line development & bioprocess technologies such as BLI Beacon & Ambr, it has become critically important to understand and de-risk the sequence associated liabilities & molecule chemical degradation pathways. This helps streamline the fermentation and purification processes and reduces the need for extensive bioprocess development in the future. Recently implemented data informatics approaches also enable live data review resulting in decisions on molecule developability being made faster than ever.

Start with the end in sight: Developability & improved biopharmaceutical molecule quality

2019 Spring National Meeting

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.