BRI is a contract research organization (CRO) supporting pharmaceutical and biotechnology companies with their discovery, preclinical, and clinical drug development programs.
BRI is accredited by Standard Council of Canada for its GLP compliance. Its successful track record in providing accurate and quality data in conformance with GLP, GCP and cGMP regulations within USFDA, OECD and MHLW (Japan) ensures that you achieve your development goals.
CELEBRATING 20 YEARS!
For more than two decades, BRI’s experienced scientists have been delivering high quality data in DMPK and a broad array of LC/MS/MS bioanalytical assays with specialization in biomarkers, nucleotides, peptides and synthetic small molecule drugs in support of GLP PK/TK pre-clinical studies and clinical Phase I to IV trials. BRI’s pre-clinical development services also includes in vitro and in vivo drug metabolism studies, and specialized patient tumor xenograft efficacy mouse models in support of late-stage drug candidate optimization and selection.
THE SUCCESS STORIES
In 2004 and 2007, two virtual biotech companies located in San Francisco and Los Angeles engaged BRI for development of bioanalytical assays in support of their IND-enabling and clinical program. In 2009, both companies licensed their drug candidates to big pharmaceutical companies for $700 million and $900 million, respectively.
A Seattle biotech company approached BRI in 2008 for a series of in-vivo and in-vitro DMPK and mechanistic studies. This biotech company was acquired for $600 million in 2011.
BRI’s successful track record in providing accurate and quality data while adhering to the strict guidelines of GLP, cGMP and FDA regulations has played an important role in these companies’ success.
Use of the Thermo Scientific Watson LIMS™ data management system dramatically increases our efficiency through automation, enabling us to handle sponsor protocols rapidly and cost effectively. A critical tool in our laboratory infrastructure, it allows BRI to generate highly consistent and reproducible data.
With 14C nuclear substance license, control substances license and AAALAC accreditation, BRI is known for providing fit-for-purpose world class research in integrated drug development and discovery. We pride ourselves on our outstanding record of client satisfaction and are dedicated to meeting the highest standards in scientific best-practices.
BRI has been successful in delivering bioanalytical assays supporting GLP preclinical tox and clinical phase I to IV development. To capture the in vitro metabolism area, BRiVALTM was created to provide an identity in the DM/PK community requiring in vitro and in vivo metabolism studies. Similarly, Oncograph TM was created to provide recognition of our patient-derived primary tumor xenograft mouse models as leading in vivo models supporting the discovery and optimization of new anti-cancer drugs and enabling translational clinical development.
Bioanalytical Assay for Measurement of Drug Candidates, Metabolites and Biomarkers
– LC/MS/MS assay method development and validation
– Small molecules, peptides, small nucleotide drugs and metabolites assays
– Clinical PK sample collection kits and data handling
– Equipment rental to clinical sites including -70oC freezer and refrigerated centrifuge
– Clinical PK non-compartmental data analysis
In-Vitro Drug Metabolism / ADME
– Screening and definitive plasma protein binding
– Hepatocytes, microsomes, S9, rCYP450 and rUGT studies including: (metabolic stability, P450 pathway phenotyping, inhibition, TDI and induction studies)
– Metabolite ID 14C-radiolabeled and non-labeled drugs
– Metabolic induction screening
– Covalent binding screening and rank-ordering
– Anaerobic Metabolism in pooled human fecal homogenate
In Vivo DM/PK/ADME
– Rapid rat and mouse PK based on Oral/IV/SC/infusion dosing
– 14C-Radiolabeled and non-labeled drug metabolism
– 14C-Radiolabeled drug tissue distribution mass balance
– Drug and metabolite mass balance excretion in metabolic cages
Formulation Development, DS/DP Stability and Analytical CMC Assays
– Drug substance API impurity profile
– Drug product specification design and assays
– Forced degradation studies and stability evaluation under ICH conditions
– Oral and parenteral clinical formulation development with excipient compatibility evaluation
Anticancer Drug Pharmacology – Oncograph™
– patient-derived primary tumor xenograft mouse model
– personalization of chemotherapy for patients
– accelerating the translational development of new anticancer drug candidates