Preclinical Bioanalysis of Large Molecules
Preclinical Bioanalysis of Large Molecules Services
The preclinical bioanalysis of large molecules is focused on the analytical needs supporting IND-enabling studies for a large molecule-based therapeutic product. Pharmaron’s bioanalysis teams perform studies (PK, TK, immunogenicity, immune response and biomarker analysis) in GLP-compliant laboratories that meet the regulatory requirements for an IND submission. Bioanalytical methods are developed and/or validated fully, followed by sample analysis and data processing and reporting. The tech team has been supported extensively by in-house QA and RA teams. Pharmaron’s laboratories have been inspected by FDA, OECD and NMPA agencies successfully since inception.
- Assay development, transferred and kit-based assay optimization to support the bioanalysis of therapeutic biologics for programs in a preclinical development phase
- Assay development, transferred and kit-based assay optimization for the analysis of ADA, ADCC, CDC and ADCP, TDAR and NAb, etc.
- Assay development, assay transferred and kit-based assay optimization for analysis of biomarkers of interest
Capabilities
Analytical Platforms
- MSD
- ELISA
- HELISA
- FACS
- Luminex
- qPCR
- ddPCR
- HPLC
- LC/MS, imaging-based methods including immunohistochemistry, liquid-handling automation station
Analytes
- Recombinant proteins, peptides
- Antibodies, e.g. mAbs, ADCs, PDCs, Bis-Abs, nanobodies
- Vaccines
- Biomarkers: DNA, mRNA, small molecule-based
- Cellular and gene therapy products
- Oligonucleotides
- siRNAs
- DNA and mRNA vaccines
- Immune therapy cellular products
- Stem cell products
- Adenovirus, Adeno-Associated Virus (AAV), herpes simplex virus, lentivirus, oncolytic virus, retrovirus, poxvirus
- Non-viral vectors e.g. plasmids
Areas of Application
- PK, TK and PD studies
- Dose formulation analysis
- Biodistribution analysis
- Immunogenicity analysis
- Immunophenotyping analysis
- Cytokine release assays (in vivo & in vitro)
- Receptor occupy analysis (in vivo & in vitro)
- Tissue Cross Reactivity (TCR) evaluation
- Biomarker analysis
- Assays for IND filing purposes are validated per GLP guidelines by ICH/FDA/EMA/NMPA
Learn more about Pharmaron’s large molecule bioanalytical services
