Biopharmaceutical companies often need to transfer analytical liquid chromatography (LC) methods within their own organization and/or to external contract organizations. Among these LC methods, reversed phase (RP), size-exclusion chromatography (SEC), and ion exchange (IEX) are commonly used to characterize biomolecules. Biocompatible or bio-inert LC systems are frequently chosen for SEC and IEX analysis due to conditions requiring aqueous mobile phase with high salt concentrations. The materials used to build biocompatible or bio-inert LC systems typically include MP35N, a nickel-cobalt alloy, titanium, or polyether ether ketone (PEEK), just to name a few. Those materials can reduce potential corrosion from high salt concentration and avoid oxidation of the protein by the presence of iron ions. In many cases, the same LC systems would be employed for RP analysis as well.
A chromatographic separation is impacted by numerous factors, including the LC system and its characteristics. The impact of the chromatographic system on the separation may not be obvious until the method is transferred to another LC system or scaled to a different column dimension. By characterizing the system and understanding these differences, strategies can be undertaken to increase the success of methods transfer. These approaches can use software or hardware tools – including the ACQUITY™ instrument control software – or follow the USP <621> Chromatography guidelines for scaling to translating methods.
In recent years, the increased number of method transfer failures has led to greater transfer scrutiny by industry and regulators. And for good reason. Simple paper transfers between sending and receiving units and provision of ambiguous information are widely regarded as insufficient. These outdated practices are now being superseded by more proactive approaches to support successful method transfer, including the provision of method transfer packages and improved lab-to-lab communication.
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