Metabolite Identification & Method Development
At Sygnature Discovery, our DMPK services are designed to deliver high-quality data that informs critical decisions throughout the drug discovery and development process. Our Metabolite Identification and Method Development services provide essential insight into a compound’s metabolic fate and support the generation of robust, fit-for-purpose analytical methods. Combining state-of-the-art instrumentation with deep scientific expertise, we help de-risk candidate selection, improve translational relevance, and accelerate your path to the clinic.
In Vitro Metabolism Studies for Predictive Drug Metabolism Insights
Metabolite Identification
Understanding how a drug is metabolized is critical to predicting its behaviour in humans and ensuring the relevance of preclinical models. Our Metabolite Identification (Met-ID) services focus on characterizing the metabolites formed during drug biotransformation, providing insights into their potential impact on safety, efficacy, and drug-drug interactions.
Using in vitro metabolism studies such as human hepatocytes and liver microsomes, we simulate human metabolism to identify and profile drug metabolites. This metabolic profile is then compared with those observed in preclinical species to establish translatability between animal models and human physiology.
Our team leverages high-resolution accurate-mass spectrometry (MS) to sensitively detect and characterise both major and minor metabolites. We apply both targeted and data-independent acquisition methods to uncover metabolic liabilities and support structure elucidation and comprehensive metabolite profiling.
By integrating advanced analytical techniques with expert data interpretation, our met-ID services support candidate optimisation, cross-species comparison, and regulatory submissions—helping ensure the safety and success of your drug development program.
Method Development
Our bioanalytical method development services are tailored to provide robust, sensitive, and reproducible analytical methods essential for the accurate quantification of parent compounds and their metabolites across various biological matrices.
Leveraging advanced analytical platforms, including ultra-high-performance liquid chromatography (UPLC) coupled with tandem mass spectrometry (MS/MS), we develop and optimise methods to meet the specific requirements of each project. These approaches underpin high-throughput UPLC-MS/MS analysis and ensure reliable support from discovery through to regulated studies.
Our process involves a collaborative approach, working closely with clients to understand the unique characteristics of their compounds and study designs. We focus on method development and optimisation for complex matrices such as plasma, urine, bile, and tissues, ensuring cross-species applicability to support in vitro-in vivo extrapolation.
Our methods are designed to be transferable and validated, facilitating seamless integration into later-stage studies and regulatory submissions. By combining scientific rigour with flexible study designs, our Method Development services aim to streamline your drug development pipeline, delivering decision-enabling data to advance your therapeutic candidates with confidence.