R&D Research & Development
The research and development phase encompasses the full spectrum of analytical activities that accompany a therapeutic candidate from the earliest stages of discovery through to its preclinical characterisation. In this environment, speed, scientific flexibility and the ability to generate quality analytical data under non-regulated conditions are as important as technical rigour: R&D teams need fast, reliable answers that enable informed decisions on candidate selection, compound optimisation and preclinical study design.
AMSbiopharma provides comprehensive analytical support for pharmaceutical and biotechnology R&D programmes, covering everything from early compound characterisation and biomarker analysis to bioanalysis of drug and metabolites in biological matrices and support for DMPK and metabolism studies. Our R&D services are conducted in non-regulated or low-regulation environments, tailored to the needs of exploratory and candidate selection phases, without the formal requirements associated with regulated studies.
Analytical support for non-regulated preclinical studies is one of our core capabilities in this area: drug quantification in plasma, serum and tissue from animal models, biomarker analysis for efficacy and safety, metabolic profiling and characterisation of drug-target engagement provide the foundational data that inform programme progression decisions and guide the design of subsequent studies.
Our scientific team works in close collaboration with the research teams of pharmaceutical and biotechnology companies, providing direct scientific interaction and the flexibility needed to adapt to the timelines and specific requirements of each drug development programme.
What does analytical support in R&D cover?
Analytical support in R&D covers a broad spectrum of needs that evolve as the programme advances. In the earliest stages, the focus is on the chemical and structural characterisation of the candidate compound, evaluation of its physicochemical properties and determination of its stability profile in relevant matrices.
As the programme progresses towards preclinical studies, analytical support expands to include quantification of the drug and its metabolites in biological matrices from animal species, analysis of response and safety biomarkers, and characterisation of pharmacokinetic and pharmacodynamic interactions. All of this information provides the knowledge base needed to take well-founded decisions on candidate progression.
Services for non-regulated preclinical studies
AMSbiopharma offers specific analytical support for preclinical studies conducted in non-regulated environments, where the priority is to obtain quality data with the speed demanded by research timelines.
Drug quantification in plasma and tissue from animal models, analysis of drug-related metabolites and impurities, profiling of efficacy and safety biomarkers, and assessment of drug-target engagement are among the capabilities that AMSbiopharma makes available to preclinical research teams. Our analytical methods are designed to be robust and reproducible from first application, minimising the number of iterative experiments and accelerating decision-making.
Therapeutic areas and modalities
AMSbiopharma’s R&D services are applicable across all therapeutic areas and for all drug modalities: small molecules, synthetic peptides, oligonucleotides, biologics and advanced therapy products. This versatility enables us to support sponsors regardless of the chemical or biological nature of their therapeutic candidate.
To learn more about AMSbiopharma’s analytical capabilities for your R&D programme, we invite you to contact our scientific team.