Frontage’s biologics teams have an average 10 – 15 years in complex drug development and have worked with large molecule applications throughout its evolution in product development. We can handle projects for a range of large molecule development projects including peptides, proteins, monoclonal antibodies, bispecific antibodies, biosimilars, oligonucleotides, biomarkers, and antibody drug conjugates. We have built a reputation for solving technical challenges related to assay development and validation.
- Method development, transfer and validation
- PK/TK – Pharmacokinetics assays
- Macromolecule PK/TK (hybridization and immunoassays)
- Immunogenicity assays (vaccine and anti-drug antibody assays)
- Cell based assays
- Functional in vitro assays
- Toxicity & viability
- Biomarker services for drug development
- Esoteric and complex assay development
- Labile compounds
- Tissue sample analysis
- Antibody Drug Conjugates (ADC)
- Determination of drug/antibody ratio (DAR) for ADC projects
Frontage offers the latest, state-of-the-art instrumentation for large molecule analysis. In addition, we offer Watson LIMS, a validated freezer temperature monitoring system, central security alarm monitoring and 24-hour card controlled facility access ensures the highest levels of data integrity.
Frontage’s bioanalytical labs are compliant with internal standard operating procedures (SOP), Good Laboratory Practice (GLP) and CLIA Certified Laboratory. Our audit history with regulatory authorities and client inspections is virtually spotless. In addition to our stringent SOPs, Watson LIMS, e-Notebook and a validated freezer temperature monitoring system, central security alarm monitoring and 24-hour card controlled facility access ensures the highest levels of data integrity.