Custom Biologics™ has been participating in the drug development programs of the biopharmaceutical, nutraceutical and veterinary industries for over 10 years.
Our small molecule bioanalytical team consists of highly trained, analytical scientists with over 30 years of combined expertise in developing and validating regulatory-compliant bioanalytical methods for quantifying drugs, novel chemical entities and metabolites in different biological matrices.
We take pride in delivering sophisticated bioanalytical solutions customized to specific bioanalytical needs. Our areas of expertise include:
Bioanalytical LC-MS/MS and HPLC-UV analysis
- New chemical entities, peptide therapeutics, antisense oligonucleotides
- Hybrid immunoaffinity/LCMS.
- Medical marihuana potency levels and profiles of tetrahydrocannabinol and cannabidiol
- Mycotoxins (aflatoxins), pesticides and terpines
Custom LC-MS/MS and HPCL-UV: Method development and validation studies.
- Pre-clinical and clinical PK studies
- Bioequivalence studies (Phase 1 to Phase 3)
- Dose formulation analysis
- Drug-Drug Interference (DDI) assays
- Drug Metabolism and Pharmacokinetic (DMPK) studies
- In vitro microsomal stability studies
- CaCo-2 Adsorption Studies
Contact us to learn how we can provide regulatory compliant, bioanalytical solutions for your testing needs.