GEN-MKT-18-7897-A
Apr 2, 2019 | Biopharma, Blogs, Pharma | 0 comments
New technologies can transform a laboratory’s throughput and efficiency. At Alturas, if we try out a new technology, we ask:
When we look at the convenience, uptime, and overall data that we’re getting from microflow LC-MS/MS with the SCIEX OptiFlow™ Turbo V source – we know we’re getting better results.
In our work, we analyze large molecules from biological fluids and matrices. The traditional approach, using ligand binding assays, can have real selectivity problems – sometimes even stopping a therapeutic in late stage development. Microflow LC and an optimized source system has us declaring: Problem solved!
I recently gave a webinar called, Soup to Nuts of Large Molecule LC-MS/MS Bioanalysis, and you can watch it on-demand now >
In this blog, I’ll share a Q&A based on some of our experiences. It might have you asking if you should switch to microflow LC-MS/MS for your large molecule bioanalysis, too.
Eight Things You Want to Know About Microflow LC-MS/MS and the OptiFlow Turbo V Source
We hope our answers have been helpful to you! If you’d like more details about our work, please watch this video.
Learn more about the SCIEX OptiFlow Turbo V Source >
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.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
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