In our preclinical CRO services, studies evaluate drug safety, efficacy, and suitability, determining dosages, identifying side effects, and preventing delays. Sannova offers high-quality analyses to address ethical concerns and ensure efficacy before clinical trials. With experience in various animal matrices, we develop reliable methods for regulatory compliance, empowering clients. Our team of experts provides invaluable assistance in navigating the transition from animal studies to human trials, ensuring that the methodology is adapted and optimized at each stage as the variables evolve.
Peptide bioanalysis faces significant challenges in managing matrix interference effects from biological samples. While ELISA has been a standard method offering high sensitivity and throughput, it struggles with cross-reactivity and selectivity limitations. Liquid chromatography-mass spectrometry (LC-MS) has proven to be more effective, though it demands careful sample preparation to minimize matrix effects and ion suppression.
Trapped Ion Mobility Spectrometry (TIMS) ) stands out as particularly valuable, delivering enhanced sensitivity,, and the capability to differentiate between peptide modifications. The development of robust bioanalytical methods that overcome matrix interference is essential in pharmaceutical development, as these methods directly influence the quality of preclinical and clinical trial data, ultimately impacting drug development decisions, safety assessments, and overall cost-effectiveness.
High-Resolution Mass Spectrometry (HRMS) is increasingly replacing triple quadrupole mass spectrometry in pharmaceutical bioanalysis, particularly for studying biologics and peptides. While triple quad MS offers superior sensitivity for single fragments, HRMS demonstrates better performance when analyzing multiple fragments and larger biological molecules like antibodies. The Thermo Scientific Orbitrap Exploris 240 instrument exemplifies these advantages, offering enhanced stability for intact proteins, improved detection speed, and better signal-to-noise ratios.
HRMS’s significance is highlighted by its role in mapping the human proteome and its acceptance by regulatory agencies like the FDA for pharmaceutical quality control. Its key advantages include greater selectivity, improved mass accuracy, and the ability to analyze larger molecules, making it particularly valuable for complex targets despite triple quad MS remaining preferred for smaller molecule analysis.
Addressing Bioanalytical Method Development Challenges from Preclinical to Clinical Trials
Choose Sannova's preclinical CRO services for exceptional quality, personalized services and excellent results, all delivered as quickly as our commitment to excellence allows