Characterisation and Comparability of Biosimilars

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1 Characterisation and Comparability of Biosimilars

2 Experience Industry Leading Technical Expertise Industry leading experience working with over 10 biosimilar molecules and 30+ biosimilar developers Industry Leader Characterisation and comparability of biosimilar monoclonal antibodies Reduce Speed to Market The most comprehensive range of off-the-shelf assays for biosimilar characterisation and comparability to ensure the most cost effective results Greater Quality Assurance Excellent regulatory and industry insight for generating data required for regulatory submissions BioOutsource offer a variety of methods to support the testing of a wide range of biosimilar monoclonal antibodies including: Herceptin (trastuzumab) Humira (adalimumab) Enbrel (etanercept) Avastin (bevacizumab) Remicade (infliximab) Yervoy (ipilimumab) Stelara (ustekinumab) Orencia (abatacept) Lucentis (ranibizumab) Synagis (palivizumab) Rituxan (rituximab) Actemra (tocilizumab) Our in-house R&D Department continually add to the molecules we support, and extend the range of assays available for molecules already in our service portfolio.

3 Complete Solution BioOutsource partner with biosimilar clients at the following stages of the development pathway: Cell Line Development Clone Selection Process Optimisation Product Characterisation Comparability Commercialisation Our highly experienced scientists have developed binding and functional cell based bioassays in line with regulatory requirements to evaluate the multiple mechanisms of action of biosimilar monoclonal antibodies in comparison to the originator molecule. ADCC Human PBMC /NK cells Promega modified jurkat cells Fab binding assays Target binding using ELISA, MSD or Biacore VEGF (165, 121a, 189) HER2 stnfa CD20 mtnfa Binding Assays Functional Assays CDC Rabbit complement Human complement L-929 & U-937 cell death assays U-937 apoptosis assay Fc binding assays Fcy Receptor I, IIa, IIb, IIIa(V), IIIa(F), IIIb, FcRn (SPR) C1q (ELISA) Antigen neutralisation bioassays Adhesion assays (ELAM, ICAM-1, VCAM-1) Promega Glo-Response VEGF neutralisation assay

4 Biosafety Testing In addition to our bioanalytical characterisation expertise, BioOutsource also offers a suite of assays to assess the safety of biologics throughout the drug development pathway. Our scientists have a wealth of knowledge and experience in biosafety testing with a thorough understanding of the regulatory requirements for biosimilar monoclonal antibodies and the cell lines used to manufacture these products. Microbiological contaminants Sterility Mycoplasma Morphology Appearance & Identity Biosafety Tests RAPD Adventitious agents In vitro assays In vivo assays FPERT Viral safety testing Retroviruses Infectivity assays Species specific viruses TEM MAP & HAP Sequencing Bovine & Porcine Genetic analysis Southern blot Real-time PCR Gene copy number Endotoxin Other key assays Abnormal toxicity Residual impurities (DNA/HCP)

5 Sartorius Stedim BioOutsource Global Facilities For further contacts, visit Glasgow, UK Laupheim, Germany New York, USA Pangyo, South Korea Glasgow 1Technology Terrace, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA, United Kingdom Phone Fax Laupheim Sartorius Stedim Cellca Erwin-Rentschler-Str Laupheim, Germany Phone: Fax: Pangyo 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, South Korea Phone Fax Bohemia 5 Orville Drive, Suite Bohemia, New York, United States Phone Fax Specifications subject to change without notice. Printed in the EU on paper bleached without chlorine. Publication No.: S e Order No.: Ver