Large molecule bioanalytical includes a wide range of technologies and techniques to ensure assays are fit for purpose to each program/study needs. Lovelace Biomedical has the facility, equipment and scientific expertise to meet your needs in large molecule studies from lead selection to pharmacology to regulatory submission. This includes methods to support pharmacokinetics, toxicokinetic, bioavailability and biomarker methods. The technology platforms these methods leverage include binding methods (ELISA, MSD), flow cytometry and cell-based assays. Lovelace can support the development, transfer, validation and sample analysis (regulated or non-regulated) for your program. Our current SOP’s meet the current regulatory guidance with regards to GLP requires for both PK/TK methods and biomarkers. This breadth of experience makes Lovelace Biomedical your partner for large molecule bioanalysis.
Our large molecule laboratories utilize state of the art equipment, a wide range of technology platforms and established relationships with regulatory experts to our clients. These methods support peptide/protein, antibody, vaccine and cell and gene therapy drug development. Lovelace offers a single site with the capabilities to develop/transfer/validation and analyze samples all while meeting current regulatory requirements.
- BD FACSymphony Flow Cytometry
- Molecular Diagnostics Plate readers
- KingFisher sample purification systems
- Meso Scale Discovery
- Luminex Technologies
- Tecan/Eppendorg/TomTec Liquid Handlers
- Biomarker Methods
- Method Development
- Method Transfer
- Method Validation
- GLP Sample analysis