GEN-MKT-18-7897-A
Jul 1, 2019 | Blogs, Clinical | 0 comments
Steven Wong, Ph.D., DABCC (TC), FACB, Past President AACC, Professor of Pathology, serves as Director of the Clinical Chemistry and Toxicology Core Laboratory and is Co-director of the Clinical and Translational Mass Spectrometry Center at Wake Forest School of Medicine with over 37 years of experience.
Elizabeth Palavecino, MD, serves as Medical Director of Clinical Microbiology and is Co-director of the Clinical and Translational Mass Spectrometry Center at Wake Forest School of Medicine.
Q: Please share details about your institution.
Wake Forest Baptist Medical Center is a nationally prominent academic medical center in Winston-Salem, NC, with an integrated health care network. The Health System includes an 800+ bed hospital serving both an adult and pediatric population with many specialty centers including Cancer and Transplant.
Q: What are your key translational research areas and goals?
We created this translational research unit to look at ways to create new tests for clinical purposes. For example, we have a large population of immunosuppressed patients, so we need a way of testing immunosuppressants or antifungal panels in a rapid way, but also in a very accurate and reliable way. That’s why we started developing these tests using mass spectrometry. Additional focus areas include acute kidney injury, drug toxicity, breast cancer, renal metabolomics, and personalized medicine approaches.
Q: How has implementing mass spectrometry helped allow your institution to provide the best patient care?
Mass spectrometry is no longer confined to the research lab but is becoming part of the routine testing in clinical labs. It was really a clinical necessity for our lab. Mass spectrometry can give me the answer reliably because it is very specific and only requires a very small volume. By bringing the test in house, the turnaround time improved drastically, from 3-4 days to 8-24 hours. That really helped improve patient care.
Q: Why is the SCIEX Citrine™ MS/MS system the right tool to further your diagnostic work?
First is the performance of the mass spec. It has higher sensitivity and is more flexible. Because we are getting it from the same source, it allowed us to establish redundancy in our testing with the two existing mass spec. The enhanced sensitivity allowed us to engage in low-level toxicology testing. The most infamous example right now is fentanyl which is a very potent drug in low concentration. The sensitivity of the newer mass spec allowed us to do an adequate detection of a very highly potent drug like fentanyl.
We have also had extremely positive interactions with both the support service teams within SCIEX as well as the quick response to our needs and are very pleased with that.Learn More About SCIEX Systems >
Finding the right information shouldn’t slow you down. Whether you’re troubleshooting your mass spec, learning something new, or optimizing performance, access to the right resources at the right moment makes all the difference.
As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
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