David Gordon is manager at the department of immunoassays and biopharmaceuticals for preclinical biosciences at the Aptuit facility in Verona, Italy. With 20 years of experience in the CRO/pharma industry, David immediately grasped the advantages of Gyrolab® technology at the theoretical level and soon appreciated the strengths of the system in practical terms — rapid turnaround, ease of use, and the advantages that immunoassays at nanoliter scale bring. “With increasing regulatory pressure to do more than just bioanalysis of samples, it’s a major advantage being able to run immunoassays on a few microliters of sample, leaving the rest for other studies. This is a distinct advantage over the 50 microliters or so consumed by regular ELISA.”
Aptuit is currently using Gyrolab technology to develop an assay to quantify a protein drug under development by a client. The assay will be validated for regulatory studies. Future plans for Gyrolab workstations include more applications in preclinical and clinical work, including ADA, and may also include the support of commercial manufacturing in other parts of the company. “Aptuit can now provide commercial and post-commercial production of biological drugs at our U.S. and UK facilities. Gyrolab technology clearly has potential here, in the measurement of process impurities in the production of biological drugs at the GMP level.”
Aptuit present themselves:
Founded in 2004, Aptuit is a pharmaceutical services company that delivers early to mid-phase drug development solutions by applying scientific excellence, outstanding service and a team of some of the foremost scientific professionals in the industry.
These drug discovery and development professionals offer proven experience in key therapeutic areas. They share a legacy of success, having advanced a large number of molecules efficiently, expeditiously and economically, from early discovery through clinical development with low attrition rates.
It is our uncommon expertise that allows Aptuit to identify the unexpected, mitigating risks and maximizing promising possibilities, ensuring exceptional results through an open, transparent climate of trust that our clients can count on.
Find out more at www.aptuit.com.