Amador Bioscience

Overview

Amador Bioscience describes itself as a global CRO offering translational science, clinical pharmacology, bioanalysis and biomarkers, and regulatory submission services in the US, China, and Europe. The company positions its work as a bridge from early research through approval, and states it is a full-service CRO for drug development from preclinical research to Clinical Phase IV studies.

Bioanalysis and biomarkers

• Immunoassays for protein and oligonucleotide therapies, biomarkers, and anti-drug antibodies (multiplex and ultrasensitive ELISA, MSD, Gyrolab, Luminex, SPX)
• LCMS for antibody-drug conjugates, oligonucleotides, peptides, small molecules, and biomarkers (HR and triple quad MS)
• Cell-based assays, including neutralizing anti-drug antibody and activity-based biomarkers
• Flow cytometry for cell therapy and biomarker work, such as immunophenotyping and receptor occupancy
• ELISpot assays for vaccine efficacy and cell-mediated immune response
• Molecular biology for cell and gene therapy, RNA vaccines, and gene editing biomarkers (qPCR, ddPCR, RNA-Seq, NanoString, NGS)
• Immunogenicity assessment, including risk assessment, assay development and validation, and regulatory documentation such as integrated immunogenicity summaries

The company states it performs in-house GLP and GcLP sample analysis and operates three GLP compliant laboratories.

Clinical pharmacology

• Noncompartmental PK/TK analysis and reporting
• Statistical programming, including SEND and SDTM datasets, and SAS-based tables, listings, and figures
• Translational modeling and simulation for clinical PKPD projection and first-in-human dose recommendations
• Population PKPD modeling, exposure-response analysis, and quantitative systems pharmacology
• Model-informed drug development to support dose selection, trial design, and NDA, BLA, and MAA filings

Regulatory affairs and clinical research

Amador describes global regulatory and operational expertise for go-to-market goals. Its clinical research offering includes project management, clinical research, and biometrics, and it highlights a network of therapeutic-specific key opinion leaders and pre-qualified investigator trial sites in the United States, Europe, and China.

Leadership

The company states its leadership team has more than 100 years of combined industry experience.