Method Transfer Process

Method Transfer typically begins with a method acquisition phase wherein we demonstrate that we can reproduce the methods spectra and/or chromatograms and meet system suitability parameters. Following the acquisition, we qualify the method via an abbreviated evaluation of the method's quantitative performance (linearity, accuracy, precision). Once a method has been qualified, we can employ that method routinely whether as part of a raw material qualification program or batch release testing. Methods include large molecules (oilgos, peptides and proteins) and small molecules as well as novel biopolymer compounds.

We simplify the Method Transfer process by assigning dedicated laboratory notebooks for each study phase. Notebooks and all associated data (spectra and chromatograms) are scanned electronically for fast and easy review and/or retrieval – no missing or complicated notebooks, no delays in searching, no problem for tracking.