Bioanalysis for Biomarkers

Bioanalytical support through the entire paradigm of discovery PK to clinical proof of concept studies

With decades of experience in developing and customizing chromatographic methods for the quantitative determination of small molecules, Concept Life Sciences is extremely well positioned to provide bioanalytical support through the entire paradigm of discovery PK to clinical proof of concept studies. Offering rapid turnaround of discovery pharmacokinetic and distribution studies, through non-regulatory and regulatory (GLP) TK support and ultimately Phase 1 and Phase 2 (GCP) clinical trials, Concept Life Sciences offers our clients a custom, advisory approach to solving their bioanalytical challenges.

Specialist areas of expertise

Our bioanalytical service specializes in the quantification of test compound or endogenous biomarker within in vitro or in vivo samples, enabling clients to access drug delivery mechanisms. We work to the highest industry standards and strict acceptance criteria to ensure our data is of the highest quality.

A single point of contact directs clients through the various studies within a project (method development to sample analysis) and all elements of the project are performed to the highest quality to ensure data integrity.

Each study is performed in accordance with a plan and is documented clearly for ease of any inspection. We provide standardized and tailored formal reports for method validation studies and sample analysis projects.

Concept Life Sciences prides itself on high quality, transparency, and data integrity, assuring the compliance of regulatory submissions for our clients. Our regulatory bioanalytical laboratories are GLP accredited and as such have the capability to develop and validate fully compliant methodologies in support of GLP bioanalytical studies.

In addition to bioanalytical determinations, our labs also support biomarker assays and in vivo biotransformation.

Non-regulatory and GLP

Our highly experienced scientists provide a consultative approach and advice on the most appropriate approach for method development based on the complexity of our clients’ compounds. Method feasibility studies can be performed quickly to provide an indication of the level of difficulty before any subsequent bespoke method development is performed.

A robust matrix matched calibration curve is used to quantify compound in a wide range of biological matrices. Also included within the sample analysis are independent Quality Control (QC) samples. Typical extraction is performed via protein precipitation, other methods including supported-liquid and solid-phase extraction are available. Analysis performed using state of the art LC-MSMS instrumentation, with other detection techniques such as LC-UV available if required.

Methods are developed and subsequently validated to an appropriate level. This ranges from scientific validations that are suitable for early stage, investigative studies through to full regulatory validations (FDA, EMA, ICH M10 ) required to support pivotal clinical trials.

A single point of contact directs clients through the various studies within a project (method development to sample analysis) and all elements of said project are performed to the highest quality to ensure data integrity. Fast quality-assured interim data can be provided throughout the life cycle of the clinical trial.

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