GEN-MKT-18-7897-A
Aug 24, 2017 | Biopharma, Blogs | 0 comments
Biopharmaceutical development is booming and now an integral part of many pharmaceutical company pipelines. While these emerging biologics present exciting opportunities for the industry, their sophistication is challenging the limits of characterization at all stages of discovery and development.
Biologic structures are larger and more complex than traditional small molecule drugs, making characterization considerably more challenging and time-consuming. To reliably develop these biologics, and to keep pace, a new level of sophistication in characterization technologies and workflows is needed.
SCIEX hardware and software solutions have been specifically developed to reduce the complexity of biologics characterization. We bring you four technologies in a single powerful, integrated solution: based on the SCIEX X500B QTOF System and BioPharmaView™ Software. With streamlined workflows, SCIEX Biologics Solutions simplify standardized intact protein analysis, subunit analysis, peptide mapping, and comparability analyses.
But don’t just take our word for it, we can prove it too. We have demonstrated the compelling capabilities of our Biologics Solutions in the characterization the biotherapeutic trastuzumab. Trastuzumab is a recombinant IgG1 monoclonal antibody for the treatment of Her2 positive breast cancer. In this case study, we analyzed and compared trastuzumab therapeutic samples from two different manufacturers to assess comparability.Download the Full Report >
To read the full comparative study of the trastuzumab samples with X500B QTOF system and BioPharmaView Software, download the report by completing the short form on the right.
With SCIEX Biologics Solutions the complexity of biotherapeutics characterization is made routine. The powerful hardware of the SCIEX X500B QTOF in combination with SCIEX OS point-and-click software ensures that high-quality data can be acquired in just a few clicks. And BioPharmaView Software simplifies and streamlines complex characterization tasks with its straightforward “click-compare-report” format.Download the Full Report >
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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