Mass Spec capacity expanded to support residual impurities, extractables, and leachables testing
by Jon S. Kauffman, Ph.D. director, Method Development & Validation and Biopharmaceutical Services
Lancaster Laboratories has recently increased mass spec capacity with the addition of three new triple quads and a GC/MS to meet the growing demand for these services. The addition of three Thermo Scientific TSQ Vantage systems will double our current MS/MS capacity, thereby increasing our throughput to develop and qualify methods for residual impurities. Also, a Thermo Scientific ISQ Mass Spectrometer equipped with Trace GC Ultra system was acquired primarily to support extractables/leachables analysis. This GC/MS system has a nice feature that allows for source removal without venting, minimizing downtime and a redesigned ion guide to yield lower detection limits and improved signal-to-noise.
These new instruments will supplement an already well-equipped mass spec laboratory that includes LTQ-Orbitrap, LTQ Linear Ion Trap, TOF, MALDI-TOF, LC/MS/MS, GC/MS, and ICP-MS instrumentation. Although some mass spec applications are research oriented and for information only, all of the instruments in the mass spec lab must undergo Lancaster Laboratories’ full validation procedure including IQ/OQ/PQ and Part 11 Testing since data generated on them could be used for stability and release testing and require cGMPs.
“We have experienced an increasing demand for mass spec services over the last five years,” says Robert J. Duff, Ph.D., manager of Biochemistry. “Mass spectrometers are critical and necessary tools for impurity identification, leachables and extractables studies, and protein characterization among other applications.”
Recently, Thermo Scientific has provided extensive training for the mass spec users. This classroom and laboratory-based training focused on various areas, including mass spec theory and key maintenance, tuning and calibration aspects. Moreover, better software familiarization and new data mining techniques as applied to proteomics were provided. Subsequently, Lancaster Laboratories staff collaborated with Thermo Scientific specialists on specific protein characterization applications utilizing the Thermo Scientific LTQ Orbitrap. “This training and the laboratory exercises will allow us to provide more comprehensive data more efficiently. Overall, we will be able to better meet the needs of our clients,” said Dr. Duff.