Characterisation and Comparability of Biosimilars

Experience

Greater Quality AssuranceExcellent regulatory and industry insight for generating data required for regulatory submissions

Industry Leading Technical Expertise Industry leading experience working with over 10 biosimilar molecules and 30+ biosimilar developers

Reduce Speed to Market The most comprehensive range of off-the-shelf assays for biosimilar characterisation and comparability to ensure the most cost effective resultsIndustry Leader

Characterisation and comparability of biosimilar monoclonal antibodies

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)

` Lucentis (ranibizumab)

` Rituxan (rituximab)

` Remicade (infliximab)

` Yervoy (ipilimumab)

` Stelara (ustekinumab)

` Orencia (abatacept)

` Synagis (palivizumab)

` 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.

Promega™ modified jurkat cells

ADCC

CDC

Human PBMC /NK cells

Rabbit complement Human complement

L-929 & U-937 cell death assays U-937 apoptosis assay

Promega™ Glo-Response VEGF neutralisation assay

Antigen neutralisation bioassays

Adhesion assays (ELAM, ICAM-1, VCAM-1)

Functional Assays

Complete Solution

BioOutsource partner with biosimilar clients at the following stages of the development pathway:

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.

Cell Line Development

Clone SelectionProcess

OptimisationProduct

CharacterisationComparability Commercialisation

Binding Assays

Fcy Receptor I, IIa, IIb, IIIa(V), IIIa(F), IIIb, FcRn (SPR)

C1q (ELISA)

Fab binding assays

Fc binding assays

Target binding using ELISA, MSD or Biacore

VEGF (165, 121a, 189) HER2sTNFa CD20 mTNFa

Genetic analysis

Other key assays

Viral safety testing

Biosafety Tests

Microbiological contaminants

Appearance & Identity

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.

Biosafety Testing

Mycoplasma

RAPD

Species specific viruses

Southern blot

Abnormal toxicity

Gene copy number

Residual impurities (DNA/HCP)

Sterility

Morphology

Adventitious agents

Retroviruses

In vitro assays

In vivo assays

Bovine & Porcine

MAP & HAP

Real-time PCR

Sequencing

Endotoxin

Infectivity assays

TEM

FPERT

Glasgow

1Technology Terrace, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA, United Kingdom Phone +44.141.946.4222 | Fax +44.141.946.4552

Laupheim

Sartorius Stedim CellcaErwin-Rentschler-Str. 2188471 Laupheim, Germany Phone: +49.7392.96648.10 | Fax: +49.7392.96648.29

Pangyo

8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu463-400 SeongNam-Si, GyeongGi-Do, South KoreaPhone +82.31.622.5700 | Fax +82.31.622.5799

Bohemia

5 Orville Drive, Suite 20011716 Bohemia, New York, United StatesPhone +1.800.368.7178 | Fax +1.631.254.4253

Sartorius Stedim BioOutsource Global FacilitiesFor further contacts, visit www.biooutsource.com.

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New York, USA

Pangyo, South Korea

Glasgow, UK

Laupheim, Germany

www.biooutsource.com/biosimilars/

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