Biologics & Small Molecules

Advantar Labs offers customers expertise in large and small molecule drug development under GLP and/or cGMP, including method development and validation, preformulation and formulation of proprietary large molecules (biologics) and small molecule drugs as well as generics, including biosimilars.

The team leverages extensive experience from both the client side and the contract side of the Pharmaceutical Industry to ensure optimal methods are in place, stable formulations are assured and comprehensive data packages are provided for seamless regulatory filings on every project including release testing, where quality can't be compromised.

Our expertise includes:

• Pre-formulation and Formulation Development
• Analytical development and validation
• Analytical method feasibility and transfer
• Peptide mapping and characterization
• ICH stability testing for API and drug product for regulatory filings
• Biopharmaceutical drug substance and batch release testing
• Forced degradation studies
• Diagnostic kit stability and packaging
• Oligonucleotide analysis
• Antibody products and vaccines
• Reference standard development, characterization, storage and dispensing