GEN-MKT-18-7897-A
Oct 29, 2024 | Blogs, Echo® MS+ system, Pharma, QTRAP / Triple Quad, ZenoTOF 7600 system | 0 comments
Read time: 2 minutes
Drug development is a challenging process that requires diverse analytical solutions and the expertise of research scientists.
Within drug discovery confident go/no-go decisions need to be made as quickly as possible. Often, highly sensitive techniques are needed to accurately monitor concentrations of biomarkers, therapeutic candidates, and their metabolites. QA/QC laboratories need consistent performance everyday over many years.
We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.
The guide covers bio/pharmaceutical quantitative assays from discovery to QA/QC, for large and small molecules. Discussing challenges regularly faced by scientists, along with potential solutions.
Download the guide >
The guide includes comprehensive chapters addressing multiple challenges and solutions regularly faced in drug development.
Discovery
Development (Small and large molecules)
Regulatory solutions
QA/QC and lot release
Products
Download the guide here >
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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