- Developability Assessment Platform includes both manufacturability and safety assessments for early identification of potential chemical/physical stability and immunogenicity issues
- All services include a complete risk assessment report including specific mitigation recommendations, allowing companies to focus on their most promising candidate
- In combination with Lonza’s extensive development and manufacturing capabilities, the new Developability toolbox offers a complete solution from candidate risk assessment through to commercial product supply
Basel, Switzerland, 6 June 2013 - Early risk assessment has become a critical factor in biopharmaceutical drug development programs. To address this growing market need, Lonza announces the launch of their new Developability Assessment Platform. This platform is designed to reduce attrition rates and improve the ranking of early drug candidates. The prediction tools include a suite of in silico based services which assess candidates for: fitness for large scale manufacture (manufacturability) and immunogenicity profiles in humans (safety).
One of the main challenges for companies today is the increasing Research and Development (R&D) costs due in part to high attrition rates of therapeutic candidates. R&D organizations need to rapidly screen out inferior candidates with a potential low probability of clinical and commercial success. Being able to assess the manufacturability and safety at the pre-clinical stage, before large investments are made, allows companies to focus on the most promising candidate and maximize R&D spending.
Lonza is uniquely positioned to offer customers a complete Developability Assessment Platform that consists of both in silico tools and protein structure expertise. The Platform includes Manufacturability Assessment and Safety Assessment Services applicable to customers in both discovery and early stage biological 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 our 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 Organization. “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.
The movement toward early risk assessment and streamlined development processes will greatly impact the timeline of biotherapeutics to first in human studies.
For more information on Lonza’s Developability Assessment Platform, please visit www.lonza.com/developability