To assess suitability of drug candidates for large-scale manufacture and safety in humans
To address a growing market need for early risk assessment, Swiss ingredients manufacturer and supplier Lonza has launched its developability assessment platform, which includes a suite of in silico based services to assess drug candidates’ fitness for large-scale manufacture and immunogenicity profiles in humans.
The platform includes manufacturability assessment and safety assessment services applicable to customers in both discovery and early stage biological drug development.
The former analyses chemical degradation pathways and post translational modifications including deamidation, oxidation and glycosylation, as well as potential physical stability issues, most notably, protein aggregation.
The latter uses Lonza’s proprietary Epibase in silico screening tool to identify potential T-cell epitopes in target proteins that may trigger potential immune reactions in human studies.
‘The costs associated with late-stage clinical failure is an increasing area of concern for our emerging and established biopharmaceutical customers,’ said Janet White, Head of Lonza’s Custom Development Services Organisation. ‘This combination of manufacturability and safety assessment allows our customers to de-risk their candidates, supporting the ‘fail fast, fail early’ mantra.’
All developability assessment services include a full data report, including interpretation by Lonza’s structural bioinformaticians. In addition, risk mitigation recommendations will be given, including the option of protein engineering followed by expression and validation of variants using Lonza’s Light Path Custom Material Supply Service.