Home / Pharma News / SGS and DiscoverX to collaborate on bioassays for biosimilars

SGS and DiscoverX to collaborate on bioassays for biosimilars Posted 06/05/2016

Contract solutions provider SGS announced on 30 March 2016 that it had entered into a collaboration with innovative life science company DiscoverX.

DiscoverX supplies cell-based assays and services for drug discovery and development. As part of this agreement the two companies will work together to provide simple and qualified assays for functional comparability, for use in quality control, lot release and stability testing of biosimilars and biobetters.

DiscoverX already has more than 35 ready-to-go bioassays for biosimilars and biobetters. These include popular targets, such as bevacizumab, cetuximab, insulin and ranibizumab, and also include a number of biologicals that are set to lose patent protection over the next 10 years [1]. SGS has initiated the evaluation and qualification of these assays and plans to offer these as a service within a Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP) environment for clients.

The availability of commercial ready-to-assay cryopreserved cells in a qualified kit will remove the need for developers to employ challenging and time-consuming method development procedures, and enable them to rapidly advance to qualification and assay validation for potency and neutralizing-antibody assays.

‘These assays are simple to use and generate accurate, robust and reproducible results which can accelerate the process of demonstrating biosimilarity, and the development of lot release assays for drug candidates’, according to Dr Fiona Greer, Global Director, Biopharma Services Development at SGS.

Reference
1. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

Source: DiscoverX, SGS

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more