VelaLabs – A Tentamus Company now offers Analyses of Leachables & Extractables

Vienna, Berlin – In order to enlarge the service portfolio for our customers in the pharma sector Tentamus has invested in new analytical instruments. A state-of-the-art UHPLC coupled with a high resolution Q-TOF MS allows both identification and quantitation of leachable and extractable and a reliable prediction of sum formulas. Subsequently the MS/MS spectra of compounds of interest are compared with databases or reference standards. In combination with the ability to quantify, a comprehensive summary can be created and used as the basis for toxicological assessment. This further development enables the Tentamus Laboratories to offer a full one stop shop to the pharmaceutical industry.

Due to the high acquisition speed of the instrument a special algorithm collects all information, including intact mass and fragment spectra in a single run. This opens the possibility to retrospectively evaluate already measured samples and screen for certain substances without the necessity of a re-measurement, or worse, repeating of a study if a critical component is discovered during a later assessment by a toxicologist.

Furthermore a GC/MS device with a versatile automatic sample handler is in place. This allows the analysis of volatile and non-volatile compounds and therefore the conduction of all common L&E analyses is possible.

To ensure the highest level of data integrity all instruments operate under GxP.

 

About VelaLabs

VelaLabs is a world -wide acting, GMP-certified and GCLP-compliant contract laboratory that offers in-depth analytical characterization services for proteins including biopharmaceuticals, biosimilars, biologics and peptides. Combining a focused, customer-orientated approach, a highly motivated team and a broad expertise in analytical development and quality control, VelaLabs is dedicated to support customer’s needs from research activities to clinical phases up to product commercialization and market release.

About Tentamus Group

Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrochemicals, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 30 locations worldwide. More than 1,600 highly-trained staff members work in over 1 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.

 

Tentamus Group GmbH
An der Industriebahn 5
13088 Berlin
www.tentamus.com
Contact: Dr. Yvonne Pfeifer
Yvonne.pfeifer@tentamus.com
Tel. +49 30/206 038 164
VelaLabs GmbH
Brunner Strasse 69/3
1230 Wien / Austria
www.vela-labs.at

Contact: Markus Roucka
m.roucka@vela-labs.at
Tel: +43 (0) 1 890 5979 11

 

 

 

 

 

 

Tentamus laboratories in your vicinity