European Biotechnology Guide 2022

Page 152

Name

Address/P.O. Box Postal Code/City Country Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Type of Laboratory

VelaLabs GmbH A Tentamus Company

Brunner Strasse 69/3 1230 Vienna Austria DI (FH) Markus Roucka +43-1-890-597911 +43-1-890-597910 office@vela-labs.at www.vela-labs.at

IQ

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84 2006 Analytical services, contract laboratory for pharma and biotech from drug development to product release (GLP, GCLP, GMP)

Areas of Activity

Annual turnover

> €7-8m

NBS-C, Protagene, Eurofins-DiscovRx

External Collaborations

Protein characterisation, ligand binding assays, cell-based assays, microbiological / sterility analysis, non-clinical and clinical services, physico-chemical analysis

VelaLabs is a globally active GLP and GMP certified and GCLP-compliant contract laboratory that offers indepth analytical characterisation services for all types of pharmaceuticals, with a focus on biologics. VelaLabs combines a focused, customer-orientated approach, a highly motivated team, and broad expertise in analytical development and quality control. VelaLabs supports pharma and biotech companies, starting from early drug development to non-clinical & clinical phases up to product commercialisation and market release in Europe.

VelaLabs – a Globally Active Analytical Services Laboratory Characterisation / Analytical Portfolio To support the product development of pharmaceuticals such as biopharmaceuticals, biosimilars, monoclonal antibodies, hormones, growth factors, and small molecules, VelaLabs offers methods in accordance with relevant ICH guidelines from development to method validation. The analytical portfolio of VelaLabs includes: › Physico-chemical methods › Cell-based (customised) bioassays (potency, cytotoxicity, proliferation…) › Reporter gene bioassays (RGA) › Ligand binding studies (Biacore/SPR, ELISA) › Lectin microarrays / glycoprofiling › Bio-analytics for clinical testing · Pharmacokinetic (PK) · Pharmacodynamic (PD) · Immunogenicity testing (anti-drug antibodies (ADA)) › Bio-safety (BSL 2) testing capabilities

Biologics and biosimilars The analytical portfolio covers a wide range for proteins, with standard methods such as gel electrophoresis, Western blot, HPLC, and PhEU methods. For higher complex molecules like antibodies our extended portfolio covers the Fab part (e.g. target binding by ELISA,


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