Quantitative BioAnalytical Regulated Studies using LC/MS/MS or ELISA

Bioanalysis for Phase I, II, III and IV Clinical Trials We use rugged, validated methods either by LC/MS/MS or ELISA techniques.

Discovery PK and TK

Matrix can provide pre-clinical animal studies, (rats and mice) coupled with bioanalysis by LC/MS/MS or ELISA.  These early data provide early decision making information for potential drugs.

To support these studies Matrix provides quantitative information regarding animal in-vivo PK and TK.  After dosing, blood collection and centrifugation, the bioanalysis is performed using sensitive LC/MS/MS techniques.  Our staff are experts in LC/MS/MS methods development, sample preparation, separations using Liquid Chromatography and Mass Spectrometry.  Methods for early PK/TK are usually simpler and less validated than those used for Clinical Trials.  Method development and sample analysis are much quicker than with validated GLP methods.  An analog internal standard (for small molecules) is usually used due to time and cost constraints.

Excellent analytical quality is important, but we understand how critical turnaround time is for these studies.  We consider a short turnaround time an important component of the overall quality of the services we provide.

Metabolic Stability Screening

This employs microsomal incubation combined with fast analysis by LC/MS

Receptor Occupancy by Mass Spectrometry

For pre-clinical studies, this technique is much faster, less expensive and just as good as radio-labeled methods for determining true receptor occupancy of a drug.

Protein Binding Studies

Plasma protein binding affects the PK and PD properties of a drug, influencing such factors as tissue distribution, metabolism, and efficacy.  Protein binding measurements in conjunction with animal PK studies can be used to scale human pharmacokinetics and aid in the prediction of human doses.  Matrix Bioanalytical offers a variety of protein binding assays, including equilibrium dialysis, and other in vitro methods suitable for highly lipophilic compounds.

Biomarkers

The Matrix staff is expert in the quantitation of small and large molecule biomarkers using either mass spectrometry or ligand binding techniques.

In-Life Studies

Our experienced in-life staff perform PK and TK studies using rodent, canine, Minipig, Guinea Pig and NHP models. We have facilities and experience with nude/SCID mice. We can perform urine/feces and bile collection for in-vivo ADME studies. We are experienced with both early Discovery screening techniques for SAR and latter, definitive in-life studies. We provide high quality and rapid turnaround.

Ligand Binding Assays

Matrix Laboratories staff have many years expertise in Ligand Binding Assay method development, validation and sample analysis.

Ligand Binding Assays are used in a wide variety of applications. These include (but are not limited to) receptor binding assays such as affinity, displacement and ID50 determinations; quantitative analyses to support TK and PK studies; antigenicity assays, biomarker assessments, enzyme characterization and inhibition and complement system components.

Matrix Bioanalytical Laboratories offers a variety of plate based ligand binding assays for qualitative and quantitative analyses in buffer, plasma or other biological matrices.
We are experienced in performing ligand binding assays in a GLP regulated environment.