Thursday, July 07, 2022

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Fingerprinting for Equivalence in Biomedical Device Testing

Mass Spec Lab is launching a new service for our biomedical and chemical industry customers - mass spectrometry based fingerprinting of materials for equivalence assessment.

Our state-of-the-art UPLC-UV-QTof Mass Spectrometer XevoR G2-S (Waters) and ProgenesisR QI software package (Nonlinear Dynamics) have been rigorously evaluated by our scientists and found to be well-suited to provide detailed and timely chemical fingerprint and equivalence information.

What is the output of a fingerprint analysis?

 

 Simply, it is a highly specific graphic visualization of a solution's chemical components, i.e., a mass spectral fingerprint, developed from the high quality accurate mass QTof data we routinely achieve.  A material's mass spectral fingerprint can define a customer's "gold standard" for chemical equivalence.  For example, testing new lots against the "gold standard" is a powerful QC/QA tool that can be used to identify chemical differences and drift in product or raw material quality.  Infinite possibilities exist in R&D and Manufacturing as well.  Examples include polymer leachables/extractables and solubilizable materials such as surfactants, chemical raw materials, and natural extracts.

Waters Technologies, a major analytical instrumentation manufacturer, has over the years become a leader in the detailed chemical characterization of materials.  Recently, Waters acquired the LC-MS software development company Nonlinear Dynamics.  A steady stream of opportunities in biosimilars, food, and chemical materials has put Waters in a leading position for fingerprinting and equivalence testing.  Mass Spec Lab is working with Waters to improve our Fingerprinting Service for our customers.  Our customers not only benefit from the most cutting edge technologies and software provided by our partners but also from the years of practical industry experience our scientists bring to the table.

If you are intrigued and interested to know more about our chemical fingerprinting and equivalence methodologies do reach out to us - one of our experienced analytical scientists will contact you.

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