06.06.13
Lonza has launched its new Developability Assessment Platform designed to reduce attrition rates and improve the ranking of early drug candidates. The prediction tools include a suite of in silico services that assess candidates for fitness for large-scale manufacture, and immunogenicity profiles in humans in both discovery and early stage biologic drug development.
The Manufacturability Assessment Service analyzes chemical degradation pathways and post-translational modifications including deamidation, oxidation and glycosylation, as well as potential physical stability issues, most notably protein aggregation. The Safety Assessment Service uses the company’s Epibase in silico screening tool to identify potential T-cell epitopes in target proteins that may trigger potential immune reactions in human studies.
The platform services include a full data report, including interpretation by Lonza’s structural bioinformaticians, and risk mitigation recommendations, including the option of protein engineering followed by expression and validation of variants using Lonza’s Light Path Custom Material Supply Service.
“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 Organization. “This combination of manufacturability and safety assessment allows our customers to de-risk their candidates, supporting the ‘fail fast, fail early’ mantra.”
The Manufacturability Assessment Service analyzes chemical degradation pathways and post-translational modifications including deamidation, oxidation and glycosylation, as well as potential physical stability issues, most notably protein aggregation. The Safety Assessment Service uses the company’s Epibase in silico screening tool to identify potential T-cell epitopes in target proteins that may trigger potential immune reactions in human studies.
The platform services include a full data report, including interpretation by Lonza’s structural bioinformaticians, and risk mitigation recommendations, including the option of protein engineering followed by expression and validation of variants using Lonza’s Light Path Custom Material Supply Service.
“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 Organization. “This combination of manufacturability and safety assessment allows our customers to de-risk their candidates, supporting the ‘fail fast, fail early’ mantra.”