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Vetter Pharma International GmbH
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Collaborations 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
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84 2006 Analytical services, contract laboratory for pharma and biotech from drug development to product release (GLP, GCLP, GMP)
Protein characterisation, ligand binding assays, cell-based assays, microbiological / sterility analysis, non-clinical and clinical services, physico-chemical analysis
> €7-8m
NBS-C, Protagene, Eurofins-DiscovRx
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,
YOU EXPERT FOR CONTRACT YOUR EXPERT PHARMCEUTICAL FOR CONTRACT TESTING PHARMACEUTICAL TESTING
YOUR EXPERT BIOLOGICALS PROTEINS BIOSIMILARS BIOPHARMACEUTICALS ANTIBODIES HORMONES VACCINES ATMPS FOR CONTRACT PHARMACEUTICAL TESTING
Analytical Development Method Quali cation / Validation / Transfer Batch Release (EU) / Batch to Batch Comparison Cell Culture Based Assays Comparability Studies Clinical Assays (Bioequivalence) Bioanalytical Methods (PK/PD) Immunogenicity Testing BIOLOGICALS PROTEINS BIOSIMILARS BIOPHARMACEUTICALS ANTIBODIES HORMONES VACCINES ATMPS
www.vela-labs.at
SPR, FACS) and the Fc related part (e.g. Fc gamma receptor binding by SPR, C1q binding by ELISA, and biological assays that are related to the mode of action of anti-proliferation, CDC, ADCC, apoptosis). For the analysis of glycosylation patterns of proteins, VelaLabs offers an exploratory method using lectin microarray technology.
Microbiological Services
In addition, VelaLabs can also offer microbiological services, e.g., sterility testing in accordance with ISO EU pharmaceutical requirements as well as environmental control and germ identification using different approaches. Endotoxin measurements with various methods including recombinant factor C (rFC) or Low Endotoxin Recovery (LER) testing is part of the portfolio, as well as Bioburden or TOC testing.
Storage and Stability
Vela Labs can carry out stability studies in stability chambers (WEISS) and has qualified equipment for storage ranging from liquid nitrogen (LN2) and ultradeep freezers (-80°C) to walk-in cold storage rooms (-20°C/ +4°C).
Consultancy on GMP storage of test materials: VelaLabs offers consultancy on current Good Manufacturing Practice (cGMP) and current Good Clinical Laboratory Practice (cGCLP) with a main focus on analytics.
Location and Lab Space
VelaLabs is located in Vienna and has a total area of 2,600 m² (laboratory and office spaces), of which approximately 1,200 m² are GxP laboratory spaces including a state-of-the-art bio-safety level 2 (BSL2) laboratory.
We are looking forward to supporting your analytical needs and will be happy to advise you personally: +43-189-059-7911
