Large Molecule Bioanalytical Services

BASi® continues to expand its bioanalytical services in the area of large molecule bioanalysis; protein-based and oligonucleotide-based therapeutics.

We develop and validate fit-for-purpose ligand binding assays (LBA) to support regulated and non-regulated bioanalysis for macromolecular drug therapeutics, immunogenicity screening, neutralizing antibody screening and biomarker analysis in biological matrices.

Our large molecule program is built upon our strong foundation of experienced scientists and project managers in conjunction with the sophisticated equipment and technology for immunoassay detection and quantification for PK/TK studies. With the increasing pressure to provide early go/no-go decisions, BASi® is well equipped to handle studies involving biomarkers as primary or secondary endpoints for indication of efficacy, safety, disease state or mechanism of action.

Services:

Method development, validation and sample analysis to support:

  • Macromolecule PK/TK analysis (ligand binding assays)
  • Biomarker services for drug development (i.e.. PD, safety assessment, mechanism of action)
  • Immunogenicity assays to determine anti-drug antibodies

Capabilities:

  • Support of ligand binding assays and hybrid ELISAs requiring colorimetric, fluorescence, luminescence and electrochemiluminescence (ECL) detection
  • Multiplexed biomarker panels by ECL detection

Validation:

  • BASi® performs validation of ligand binding assays using methods developed by BASi®, methods transferred from the sponsor, or by adapting commercially available immunoassay kits.
  • BASi® standard operating procedures (SOPs) and standard analytical procedures (SAPs) are systematically revised to meet the ever-changing regulatory and industry standards.

Instrumentation:

  • BASi® uses GLP-compliant systems for sample receipt, tracking and storage
    • Watson LIMS (Version 7.5)
  • BASi® uses GLP-compliant instrumentation for raw data capture
    • SpectraMax M5 Microplate Readers
    • Meso Scale Discovery Sector Imagers

Software

  • BASi® uses Industry-standard, FDA 21 CFR Part 11-compliant, software packages for data analysis
    • Analyte concentration determination using Watson LIMS (Version 7.5)

BASi Delivers!

  • Scientific Expertise with Proven Capabilities
  • Regulatory Excellence
  • Committed to our clients' successes
  • Rated "Best CRO' 5 years in a row by Life Science Leader