Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, has announced the launch of its new analytical platform, LabZient™. The standardized and automated platform streamlines the assessment and validation of large molecules, which significantly reduces drug development timelines and resource costs.
LabZient™ combines predictive in-silico evaluation with well-established and vetted laboratory methods that de-risk the application of platform analytical procedures. In doing so, LabZient™ removes the need for extensive method qualification testing and enables antibody critical quality attributes (CQA) to be measured with a high degree of certainty early in the development process.
Dr Louise Duffy, Chief Technical Officer at Abzena said “By leveraging our extensive analytical expertise, laboratory methods, development data, and method qualification results, we’ve created a standardized, automated process that predicts how certain antibody molecules will behave, based on a structural assessment. This unique approach provides customers with critical data sooner, allowing them to make more informed decisions earlier in their development timeline that can ensure greater downstream clinical and commercial success.”
Matt Stober, Chief Executive Officer at Abzena said: “This platform has been created based on customer feedback and industry demand. Many pharma and biotech companies have tight timelines and limited access to financing. They are seeking to introduce operational efficiencies that enable them to get to market quicker. Therefore, they stand to benefit from methodology that allows them to obtain high quality data faster. This approach also allows for streamlining analytical testing across portfolios that are based on a common modality. By working with our customers on this new approach, we look forward to expediting their pathway to IND.”
Assessments to date indicate that the LabZient™ platform methods are fit-for-purpose across a wide range of antibodies including monoclonal antibodies (mAbs), antibody fragments (Fabs) and bispecifics. Abzena is expanding the application of this approach to Antibody-drug conjugates (ADCs) in the near future.