GEN-MKT-18-7897-A
May 4, 2023 | Blogs, Pharma, QTRAP / Triple Quad, ZenoTOF 7600 system | 0 comments
Readtime: 3 minutes
At SCIEX, we are proud to provide analytical systems to the pharmaceutical industry. We work hard to understand the demands of analytical work and the processes required to develop and manufacture drugs.
While the performance of an analytical instrument is an obvious requirement, we also understand that developing a robust method is just the beginning. In one of the most highly regulated industries, it is no easy task to run a laboratory and satisfy all the relevant regulatory bodies around the world.
Much more than a metal box
If we have done our job right, our products should ease the burden of meeting regulatory requirements. SCIEX OS software is compliant-ready with features that support and enable you to be as efficient as possible and reduce the potential for human error.
For example, the user-friendly interface is intuitive, which reduces training time for scientists. Security management controls user access rights to prevent accidental changes to methods, method edits are logged for auditing and only approved users can sign off reports. These features are all designed to make your work life easier.
Meet our team
Our field service engineers and consultants are here for you, from system installation to method development and maintenance visits. You can choose a service level that meets your needs. Options include installation qualification and operational qualification (IQOQ) to ensure your system is always qualified, and that ongoing maintenance is taking place.
The qualification status of your instrument will be maintained because our engineers complete their work using good document practices to ensure you are audit-ready, giving you peace of mind. Read more about how to achieve 21 CFR Part 11 compliance with SCIEX OS software in accordance with Good Laboratory Practice (GLP).
Let’s meet a few members of the SCIEX team and hear how they help customers every day.
Greg Hart
Kimberly Warner
Laura Baker
You are in safe hands. SCIEX has delivered more than 10,000 qualifications and over 1,000 validations without any regulatory findings.
SCIEX is a partner in your laboratory. Learn more by visiting the Small Molecule Therapeutics section of our website.
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.
At SCIEX, innovation doesn’t stop at instruments; it extends to how you interact with your LC-MS/MS or CE systems every day. That’s why we’re excited to introduce the SCIEX Now spring 2026 improvements: a set of meaningful enhancements shaped directly by your feedback.
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