GREENWICH, Connecticut, Aug. 22, 2014 /PRNewswire/ — Aptuit LLC announces that Aptuit SSCI, located in West Lafayette, Indiana, has enhanced its capabilities in the areas of structure determination and characterization of small and large molecules, including biologic drugs, metabolites, and polymers, through the addition of the Bruker maXisPlus Q-TOF mass spectrometer.
In making the announcement, Dr. Jonathan Goldman, CEO, Aptuit, said, "The expanded large molecule capability enhances our early development support for the fastest growing sector of the pharmaceutical industry and provides our scientists with the ability to identify active and/or high percentage metabolites in drugs as outlined in the United States Food and Drug Administration Guidance on Metabolites in Safety Testing (MIST)."
Dr. Patrick Tishmack, Director of Analytical Development at Aptuit SSCI, explained that ultra high mass resolution is particularly important in conducting impurity assays of drug substances and drug products, with a limit of detection in the pg/mL to fg/mL range. He clarified the significance of the high sensitivity by saying, "Q-TOF mass spectrometry is a fast and accurate analytical method for characterizing low levels of analytes yet its range from 20 Da to 40,000 Da also enables the analyses of small molecules, polymers, carbohydrates, oligonucleotides, and proteins such as antibodies."
According to Dr. Tishmack, this addition brings significant value to Aptuit’s clients. "When high resolution mass spectrometry capability is coupled with Aptuit SSCI’s industry-leading expertise in solid state chemistry, the resulting data and corresponding expert scientific interpretation will be at a standard that is unmatched in the contract preclinical research industry."
The Q-TOF MS, which will be installed and operational by October 2014, will allow unambiguous assignment of molecular formulae for small molecules. In addition to faster sample analysis, generally easier method development is achieved through its implementation. The equipment’s higher throughput translates into a more rapid turnaround for a large number of samples.
For more information, please send an email to [email protected] or contact Aptuit SSCI at + 1 800 375 2179.
Aptuit LLC provides the most complete set of integrated early discovery to mid-phase drug development services in the pharmaceutical industry including Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Pharmaceutical Sciences and Aptuit INDiGO® (a fixed-cost program that accelerates drug development). Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 700 employees in Europe and the United States. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Aptuit, visit www.aptuit.com.