Developability Assessment Platform Reduces Attrition Rates and Improves Predictability of Clinical Safety

Early risk assessment has become a critical factor in biopharmaceutical drug development programmes. To address this growing market need, Lonza has announced the launch of its 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 R&D costs due in part to high attrition rates of therapeutic candidates. R&D organisations 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 maximise 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 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 Safety Assessment Service 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 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.  

Lonza Group Ltd, +44 1753 504383, shiva.khalafpour@lonza.com, www.lonza.com/developability.