Methods transferred into a new laboratory need to be re-established for regulatory compliance. The extent to which an assay has to be re-validated varies, however, most methods necessitate full validation to demonstrate their reliability.
KCAS has extensive experience in the method transfer process.
KCAS has transferred hundreds of methods over the years, often upgrading the methods in the process. Frequently this involves changing to a more sensitive instrument or a different platform to improve on the existing method. Method transfers may need to address changes in formulation, presence of co-administered agents, or application to a certain disease population, that affect assay performance.
Our scientists have extensive experience in transferring methods in and addressing most any challenge in their application for bioanalysis.
COMPOUND CLASSES
- Small Molecules
- Metabolites
- ADCs (Free and Total)
- Endogenous Molecules
- Metals
- ADCs (Mab, ADA)
- Amino Acids
- Biomarkers
- Cell Surface Receptors
- Fusion Proteins
- Glycosphingolipids
- Large Molecules (NBEs)
- Lipids
- Monoclonal Antibodies (mAbs)
- Multi-Valent Antibodies
- Novel Frameworks
- Oligonucleotides
- PEGylated Proteins
- Peptides
- Proteins
- RNA / DNA
- Signaling Pathways