Biosafety Testing for Biologics and Viral Vaccines

All biopharmaceutical and biotechnology products must undergo stringent safety testing throughout development and manufacture to ensure cells are characterised and free from contamination.

Biosafety testing within the manufacturing process should be established in the early stages of drug development. Before clinical trials the following cell banks require complete testing as well as demonstrating that the process samples are free from contamination:

` Master Cell Bank (MCB)

` Working Cell Bank (WCB)

` End of Production Cell Bank (EPC)

BioOutsource also supports the testing of:

` Bulk Harvest

` Genetic Stability

` Final Product Lot Release

At BioOutsource we have developed and validated a range of assays to characterise cell banks originating from different species including murine, hamster, human and primate and have experience working with the following products:

` Biosimilar monoclonal antibodies

` Monoclonal antibodies

` Recombinant Proteins

` Vaccines

` Gene Therapy Vectors

` Regenerative Medicine

Experience

Greater Quality AssuranceQuality driven results. Fully compliant GMP, GLP and GCP facilities

Fast Turnaround TimesIndustry leading assayturnaround times

Extensive Regulatory Knowledge Knowledge of testing requirements for release in Europe, USA, Japan and South Korea

Excellent Technical Expertise Industry leading expertise in biosafety testing of biologics and viral vaccines

Industry LeaderBiosafety testing of biologics and viral vaccines

BioOutsource partner with clients from early stage development through to commercialisation of the product:

Complete Solution

In vitro assays

In vivo assays

Bovine & Porcine

MAP & HAP

Real-time PCR

Infectivity assays

TEM

FPERT

Genetic analysis

Other key assays

Viral safety testing

Microbiological contaminants

Appearance & Identity

Mycoplasma

RAPD

Species specific viruses

Southern blot

Abnormal toxicity

Gene copy number

Residual impurities (DNA/HCP)

Sterility

Morphology

Adventitious agents

Retroviruses

Sequencing

Endotoxin

Biosafety Tests

GMP Lot ReleaseProduct Characterisation

Cell Line Development

Process Optimisation

Clone selection

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 Cellca Erwin-Rentschler-Str. 21 88471 Laupheim, Germany Phone: +49.7392.96648.10 | Fax: +49.7392.96648.29

Pangyo

8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu 463-400 SeongNam-Si, GyeongGi-Do, South Korea Phone +82.31.622.5700 | Fax +82.31.622.5799

Bohemia

5 Orville Drive, Suite 200 11716 Bohemia, New York, United States Phone +1.800.368.7178 | Fax +1.631.254.4253

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

New York, USA

Pangyo, South Korea

Glasgow, UK

Laupheim, Germany

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