GEN-MKT-18-7897-A
May 4, 2023 | Blogs, Pharma, QTRAP / Triple Quad, ZenoTOF 7600 system | 0 comments
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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 monoclonal antibody (mAb) development, assessment of purity and integrity of the protein in question is critical. CE‑SDS is the gold standard assay and is routinely run from analytical development through QC and lot release. It’s trusted because it consistently delivers quantitative, size‑based insight into purity and fragmentation, and it fits naturally into regulated environments.
In drug discovery and development, Metabolite Identification (Met ID) plays a critical role in understanding biotransformation pathways, ensuring safety, and meeting regulatory requirements. Advanced mass spectrometry techniques have revolutionized this process, particularly through electron-based fragmentation methods such as Electron Activated Dissociation (EAD) and Electron Transfer Dissociation (ETD). While both techniques leverage electron interactions to generate informative fragment ions, they differ significantly in mechanism, performance, and suitability for Met ID workflows.
In analytical laboratories, performance is not optional. Whether supporting regulated pharmaceutical workflows, high-throughput CRO operations, clinical reporting, or food and environmental testing, your mass spectrometry and capillary electrophoresis systems are critical to productivity, compliance, and scientific confidence.
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