Mass Spec Lab Origins
"Based on our long history of providing analytical support to the biomedical device community, we decided to launch Mass Spec Lab, a premier mass spectrometry facility and comprehensive analytical laboratory to address the most demanding biomedical device, pharmaceutical, biotechnology, and natural products materials and formulation challenges."
~ Marie Dvorak Christ, PhD, Mass Spec Lab founder
For more than 15 years, Marie Dvorak Christ, PhD, and F. Richard Christ, founders of Mass Spec Lab, have performed ISO 11979 and ISO 10993 biocompatibility studies for companies in the ophthalmic devices industry. These have included leachables, extractables, accelerated hydrolytic and photolytic aging, residual and trace contaminant chemical characterization and biopolymer material structural studies. Reports submitted to FDA and to notified bodies in the CE process have been pivotal to start-up companies as well as established industry giants seeking and receiving regulatory approvals as well as ongoing analysis of materials and products..
Dr. Christ has graduate and post-doctoral experience in mass spectrometry and NMR of small molecules, glycans, and peptides. Dr. Christ also has over 15 years of industrial experience in biomedical device development and testing.
Mr. Christ has graduate experience in the rheology of water-soluble polymers and 30 years of industrial experience in ophthalmic biomaterials and regulatory strategies for biomedical devices.
During the period 2012 to 2014, significant instrumentation enhancements were made to significantly expand the scientific scope and quality of the studies and reports.
2012, GCMS Was Added:
Agilent 7890A GC with 5975C mass sensitive detector (MSD) and searchable NIST Mass Spectral Library
2014, UPLC/MS/MS Was Added:
Waters Acquity UPLC I-Class with Xevo G2-S QToF mass detector and Acquity UPLC I-Class PDA detector.
In 2015, Mass Spec Lab was founded to take advantage of these and additional acquisitions. We expanded mass spectrometry services to the broader biomedical industry addressing analytical needs in the areas of:
- Engineered tissues
- Drug/device combination products
- Drug delivery matrices
2015: Mass Spec Lab Scientific Team Grows:
Dr. Greaves has had an impressive mass spectrometry career starting with work in malaria, cancer (Mount Sinai Medical Center), and environmental (College of William and Mary, Williamsburg, VA) fields and culminating with over 20 years as the director of the Mass Spectrometry Facility in the University of California, Irvine Department of Chemistry. Dr. Greaves has authored over 80 scientific papers and numerous published abstracts.
Ms. Buchen will work with Mass Spec Lab in the biocompatibility assessment and safety risk analysis for the device, biotechnology, and pharmaceuticals fields.
2015, Mass Spec Lab added Michelle S. Rose, MA, as Marketing and Communications Manager.