Using an automated CE-SDS platform in efficient biosimilar comparability studies is a free-to-attend webinar which was hosted by DDW and supported by Bio-Techne on 29 September at 4PM BST.
Watch on Demand here.
The route to market for biosimilars places strong emphasis on the analytical and characterisation techniques used to investigate the structure of the molecule and, most importantly, side-by-side comparability exercises between the biosimilar and innovator products. Both the EMA and FDA have set out clear guidelines for companies aiming to produce biosimilars, including the expectations for analytical investigation into structure. In these documents, the EMA and FDA both cite ICH Q6B as the guideline for biosimilar testing and highlight the need for using orthogonal techniques that enable cross verification of data and conclusions from different methodologies. The UK MHRA has also published its own guidance document on biosimilars with great emphasis placed on analytical data and a reconsideration of the requirement for comparative efficacy trials.
Electrophoretic data forms part of the full structural characterisation as given in the ICH Q6B guidelines as well as serving to provide orthogonal data to other structural investigations such as those using mass spectrometry.
In this webinar, Dr Richard L Easton, Technical Director of Structural Analysis at BioPharmSpec will discuss the use of the automated Maurice platform, from ProteinSimple, to provide capillary electrophoresis-sodium dodecyl sulphate (CE-SDS) data for biosimilar comparability studies. Maurice allows for both CE-SDS and icIEF (imaged capillary isoelectric focusing) analyses. These instruments are designed to significantly reduce run times (as short as 25-35 minutes) while providing high-quality and reproducible results. Through UV absorbance (220 nm), high-resolution peaks are obtained for proteins ranging from 10 kDa to 270 kDa.
Easton will present data from studies with monoclonal antibodies, heavily glycosylated species and PEGylated species showing how the Maurice 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.
