Vela Laboratories announced today that it has received the GMP
certificate for its analytical and quality control laboratories. "Good Manufacturing Practice" is a body of internationally accepted regulations set forth by EU and US drug agencies. GMP
compliance ensures that pharmaceuticals, active ingredients and medical devices are produced and quality-controlled according to state-of-the-art standards.
"GMP compliance is the gold standard in quality assurance in the life science industry. It is a major achievement for Vela Labs to have reached the GMP certification just 18 months since its formation," said Dr. Markus Fido, founder and CEO of Vela Laboratories. "Now that Vela Laboratories is GMP certified, its analytical services fully qualify to support clinical studies as well as regulatory submissions."
"GMP certification is an important milestone for our analytical services business. Now we will start to consistently expand our analytical methods portfolio that we are offering to the pharmaceutical and biotech industry," said Dr. Andreas Nechansky, founder of Vela Laboratories and Chief Operating Officer.
"Having achieved GMP compliance enables Vela to develop its therapeutic anti-cancer antibodies in the shortest time possible and with the highest quality," said Dr. Ralf Kircheis,
founder of Vela Laboratories and Chief Scientific Officer.
About Vela Laboratories
Vela Laboratories (Vela pharmazeutische Entwicklung und Laboranalytik GmbH) provides a broad portfolio of analytical methods for the preclinical and clinical development including studies in support of regulatory submissions and product release for biopharmaceuticals.
Additionally, Vela Laboratories develops innovative immunotherapeutics for the treatment of cancer, including therapeutic antibodies and multi-epitope vaccines. Vela Laboratories’ lead product, a humanized monoclonal antibody against a common tumor antigen, is in clinical development. In addition, Vela Laboratories also has development programs underway that aim at improving the efficacy and tolerability of therapeutic antibodies through targeted changes to the sugar structure of the antibody molecules.
The Company, headquartered in Vienna, Austria, was founded in November 2006. Vela Laboratories is funded by private investors, by grants from Austrian government agencies
(AWS and ZIT/LISA) and through revenues generated by its analytical services business.
Jakob Koschutnig Head Marketing & Sales Vela Laboratories Brunner Str. 69 / 3 1230 Vienna, Austria Mobile: +43 (0) 699 1314 3 123 Fax: +43 (0) 1 890 597 9-10 E-mail: j.koschutnig(at)vela-labs.at