With over 30 years of biologics drug development experience spanning PK bioequivalence to assessment of similarity of effect in patients, and many successful submissions to the EMA and FDA, Celerion provides the required services to support biosimilars development. Celerion, a leading clinical research organization, conducts immunogenicity assessment of large molecule drugs including development and validation of anti-drug antibody assays and neutralizing antibody assays, cell-based functional assays and specific biomarker assays, all supporting the pharmacodynamic assessment of biosimilars
We are a CRO specialising in the analysis of proteins and their associated PTM’s via advanced Mass Spectrometry. By using proprietary methodologies, we can detect up to 8,000 proteins per sample in Discovery mode and can offer multiplexed assays of up to 100 proteins/sample in a GCLP accredited Targeted assay.
With their proprietary bioinformatics software, these can be trimmed down to some tens of proteins that are either up-, or down-regulated with disease progression or drug treatment.
One of SERVA‘s latest technologies is “HPE™” (High Performance Electrophoresis) – a workflow in protein analysis which combines horizontal electrophoresis with superb resolution using unique equipment (HPE™ BlueHorizon™ System);
Our experts can help you to establish your workflow – from sample preparation to evaluation we will consult confidentially our customers – our know-how for your success.
Based in Washington, D.C. and renowned for more than four decades for dedication to the protection, transfer, and enforcement of intellectual property rights, Sterne, Kessler, Goldstein & Fox is one of the most highly regarded intellectual property specialty law firms in the world. Its team of attorneys, registered patent agents, students, and technical specialists include some of the country's most respected practitioners of IP law tackling innovations across a broad spectrum of industries. The firm’s practitioners hold over 50 masters and over 50 doctorate degrees in science or engineering and represent Fortune 500 companies, entrepreneurs, start-ups, inventors, venture capital firms, and universities in a client service driven environment that is welcoming, inclusive, and intellectually stimulating. Visit the firm online at sternekessler.com.
