Center for Biomedical Testing
Center for Biomedical Testing (CBT) is a comprehensive contract research organization specializing in drug development and toxicology services. With a team of highly experienced scientists and consultants, CBT provides integrated GLP-compliant testing services supporting pharmaceutical and biotechnology research from inception to FDA submission. Their expertise spans analytical chemistry, bioanalytical support, pharmacokinetics, in vivo and in vitro toxicology, reproductive toxicity, efficacy studies, and IND package design. CBT is dedicated to helping clients navigate regulatory processes efficiently and effectively, with a focus on quality, innovation, and client success.
Industries
Nr. of Employees
small (1-50)
Center for Biomedical Testing
2647 Gateway Road, Ste 105-528, Carlsbad, CA 92099
Products
IND Package Design and FDA Submission
Designs and executes IND packages for drug or device development, supporting from early efficacy proof of concept to FDA submission.
IND Package Design and FDA Submission
Designs and executes IND packages for drug or device development, supporting from early efficacy proof of concept to FDA submission.
Analytical and Bioanalytical Support
Provides GLP-compliant analytical chemistry support for non-clinical studies, including method development for various compounds and drugs.
Analytical and Bioanalytical Support
Provides GLP-compliant analytical chemistry support for non-clinical studies, including method development for various compounds and drugs.
Pharmacokinetics/Metabolism and Tissue Distribution
Offers DMPK studies to support drug candidate selection or regulatory submission, including custom-designed ADME studies.
Pharmacokinetics/Metabolism and Tissue Distribution
Offers DMPK studies to support drug candidate selection or regulatory submission, including custom-designed ADME studies.
IND Package Design and FDA Submission
Designs and executes IND packages for drug or device development, supporting from early efficacy proof of concept to FDA submission.
IND Package Design and FDA Submission
Designs and executes IND packages for drug or device development, supporting from early efficacy proof of concept to FDA submission.
Analytical and Bioanalytical Support
Provides GLP-compliant analytical chemistry support for non-clinical studies, including method development for various compounds and drugs.
Analytical and Bioanalytical Support
Provides GLP-compliant analytical chemistry support for non-clinical studies, including method development for various compounds and drugs.
Pharmacokinetics/Metabolism and Tissue Distribution
Offers DMPK studies to support drug candidate selection or regulatory submission, including custom-designed ADME studies.
Pharmacokinetics/Metabolism and Tissue Distribution
Offers DMPK studies to support drug candidate selection or regulatory submission, including custom-designed ADME studies.
Services
GLP-compliant development and validation of HPLC, LC/MS and LC-MS/MS methods to support preclinical studies, pharmacokinetics, dose verification, metabolite identification, stability and solubility testing.
Design and execution of immunoassays and protein detection methods including multiplex cytokine panels, cardiotoxicity and nephrotoxicity marker panels, and antibody detection assays across multiple species.
In vitro and in vivo ADME and DMPK study design and execution, PK parameter estimation, metabolic profiling using microsomes/S9/hepatocytes, and quantitative tissue distribution analyses.
In vitro cytotoxicity screening and genotoxicity testing including bacterial reverse mutation, mammalian chromosome aberration and micronucleus assays to inform candidate selection.
Conduct of dose range-finding, acute, subchronic, chronic and repeat-dose toxicity studies, safety pharmacology and carcinogenicity studies in rodents and large animals with GLP clinical pathology support.
Dose-range finding and ICH/FDA segment I–III reproductive toxicity studies and multigenerational studies conducted under internationally recognized guidelines for regulatory submissions.
GLP-compliant development and validation of HPLC, LC/MS and LC-MS/MS methods to support preclinical studies, pharmacokinetics, dose verification, metabolite identification, stability and solubility testing.
Design and execution of immunoassays and protein detection methods including multiplex cytokine panels, cardiotoxicity and nephrotoxicity marker panels, and antibody detection assays across multiple species.
In vitro and in vivo ADME and DMPK study design and execution, PK parameter estimation, metabolic profiling using microsomes/S9/hepatocytes, and quantitative tissue distribution analyses.
In vitro cytotoxicity screening and genotoxicity testing including bacterial reverse mutation, mammalian chromosome aberration and micronucleus assays to inform candidate selection.
Conduct of dose range-finding, acute, subchronic, chronic and repeat-dose toxicity studies, safety pharmacology and carcinogenicity studies in rodents and large animals with GLP clinical pathology support.
Dose-range finding and ICH/FDA segment I–III reproductive toxicity studies and multigenerational studies conducted under internationally recognized guidelines for regulatory submissions.
Expertise Areas
- GLP nonclinical toxicology
- IND/NDA package preparation and regulatory submission support
- Pharmacokinetics and DMPK
- Bioanalytical method development and validation
Key Technologies
- LC-MS/MS
- HPLC
- Electrochemiluminescence-based multiplex immunoassays
- ELISA and sandwich immunoassays
News & Updates
CBT developed in vitro methods for skin and ocular irritation assessment using human reconstructed 3D epithelium, following OECD Guidelines 439 and 492.
CBT developed a high throughput assessment method for anticancer drugs using patient-derived tumor organoids, supporting precision medicine.
CBT completed entire IND packages for three drugs now in Phase 1-3 clinical trials, including analytical work and PK analysis.
CBT developed new highly sensitive methods for viral antibody titers, cell-based neutralization assays, and cytokine biomarkers in various species.
CBT developed in vitro methods for skin and ocular irritation assessment using human reconstructed 3D epithelium, following OECD Guidelines 439 and 492.
CBT developed a high throughput assessment method for anticancer drugs using patient-derived tumor organoids, supporting precision medicine.
CBT completed entire IND packages for three drugs now in Phase 1-3 clinical trials, including analytical work and PK analysis.
CBT developed new highly sensitive methods for viral antibody titers, cell-based neutralization assays, and cytokine biomarkers in various species.