The route to market for biosimilars places strong emphasis on characterisation tools for establishing comparability between biosimilar and innovator products.
Addressing analytical challenges in fast-forwarding biosimilar development processes requires Implementing sophisticated analytical instruments with advanced technologies. The ICH Q6B, cited by both EMA and FDA, highlights electrophoretic data as an important part of the molecule’s full structural characterisation.
Using an automated CE-SDS platform in efficient biosimilar comparability studies is a free-to-attend sponsored webinar which will be hosted by DDW and supported by Bio-Techne.
It took place on 29 September at 4PM BST.
This event will provide expert insight from Dr. Richard L. Easton, Technical Director of Structural Analysis at BioPharmaSpec. Watch this here on demand.
Dr Easton will discuss the use of a fully automated capillary electrophoresis-sodium dodecyl sulphate (CE-SDS) platform to provide data for biosimilar comparability studies. This CE-SDS platform is designed to significantly reduce run times (as short as 25-35 minutes) while providing high-quality and reproducible critical quality attribute data, allowing method development within a day as well as enabling easy method transfer.
Easton will present data from studies with monoclonal antibodies, heavily glycosylated species and PEGylated species showing how this automated CE-SDS platform can be used to provide reliable insights into the structure of different types of biopharmaceuticals, including assessments of size heterogeneity, presence of partial species in monoclonal antibody preparations, impurity analyses, and batch to batch comparability.
This webinar will benefit anyone who is interested in understanding how to optimise their analytical methods to accelerate biosimilar development.
Watch for free here.
Image credit: ThisisEngineering RAEng