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 and large 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.
Preclinical bioanalysis (non-regulatory and GLP)
Our highly experienced scientists work closely with our clients to ensure a smooth transition from rapid, discovery PK support through non-regulatory preclinical TK assessments (such as dose range finding and maximum tolerated dose studies) into formal GLP bioanalysis that underpins TK safety assessments prior to clinical trials.
Bioanalytical requirements are tailored to support studies’ depending on their position in the discovery-development. If required, method feasibility studies can be performed quickly to provide an indication of how complex method development may be. Common microsampling techniques such as dried blood spots (DBS), capillary microsampling (CMS), Volumetric Adsorptive Microsampling (VAMS) and blood/water can be supported if required if part of in vivo study design.
Methods are then developed and if necessary validated to an appropriate level. This ranges from scientific validations that are suitable for early-stage non-regulatory studies (such as MTD and DRF), through to full regulatory validations (FDA, EMA) required to support TK safety studies. Current industry guidelines are followed, and all regulatory work is performed in accordance with GLP.
High quality, transparency, and data integrity
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. TK data analysis can be performed if required.
Concept Life Sciences prides itself on high quality, transparency, and data integrity, assuring the compliance of regulatory submissions for our clients.
Preclinical bioanalytical services
- LC-MS/MS Method Feasibility and Development
- LC-MS/MS Method Validation in accordance with current industry guidelines and to GLP when required
- Full support for all pre-clinical studies in all species
- TK data analysis (WinNonlin) available
- Microsampling techniques (DBS, CMS, VAMS and Blood/Water) fully supported
Clinical bioanalysis (GCP)
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.
Methods are then 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) 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.
Standardized and tailored formal reports for method validation
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. Fast quality-assured interim data can be provided throughout the life-cycle of clinical studies and PK data analysis can be performed for clinical studies that are not involved in regulatory decision making.
Concept Life Sciences prides itself on high quality, transparency, and data integrity, assuring the compliance of regulatory submissions for our clients.
Clinical bioanalytical services
- LC-MS/MS Method Feasibility and Development
- LC-MS/MS Method Validation (scientific, cross, partial, and full) for pivotal clinical studies performed in accordance with current industry guidelines
- Fast turnaround for early Phase I clinical trials
- Full support for bioavailability, bioequivalence, and drug-drug interaction studies
- PK data analysis (WinNonlin) for clinical studies that are not involved in regulatory decision making
Bioanalytical instrumentation and techniques
- Sciex 6500 Triple Quadrupoles
- Sciex QTrap® 6500+ with MRM3 capability for enhanced specificity
- SelexION™ differential ion mobility technology for increased specificity
- 2D-ExionLC with multi-dimensional chromatography for increased selectivity
- On-line radiochemical detection, UV (Vanquish Flex uHPLC-UV/Vis (3D data acquisition capability), and GC-MS/FID for analytical support of compounds not amenable to LC-MS/MS
- Chiral Chromatography
- Metabolite and multi-analyte methodologies
- Surrogate peptide approaches in support of large molecule bioanalysis by LC-MS/MS (Proteins, ADCs, etc.)
- Oligonucleotide analysis
