It’s Time to Make Sure Your HPLC Suits Your Analytical Needs

Most routine biopharma analytics labs have standardized equipment; repeat purchase of the same systems or slightly upgraded models. While this hplc-1may be considered the safest option for the lab, is it the best option for your samples? The majority of HPLC systems use stainless steel components due to steel’s high mechanical strength — a great characteristic for the high pressures of LC systems. However, steel is a reactive material, and this should be considered when developing new assays. As pharmaceutical companies are shifting their new development pipelines from small molecules to biopharmaceuticals, it is a critical time to evaluate the instrumentation required for successful separation of biopharmaceutical products.

The Changing Landscape of Modern Labs

Since biopharmaceuticals are created in a biological system, these therapeutics are often comprised of a pool of slight variations, hence, more of an analytical challenge to characterize compared to small molecules.  For example, changes in a biomolecule charge profile can significantly impact the structure, stability, binding affinity, and efficacy of the drug. Therefore, it is necessary to understand the charge profile so that variants are monitored and controlled throughout development and manufacturing processes. A typical method to monitor charge variant profiles during biologics production is ion exchange chromatography (IEX). Proteins are most often eluted from IEX columns by increasing the concentration of counterions (salts) in the buffer solution.

hplc-2

Representative chromatogram of monoclonal antibody charge variant analysis by IEX.

Stop Letting Your HPLCs “Steel” Your Time and Money

When running IEX mobile phases on your stainless-steel system, you may be unintentionally poisoning your columns. Salt eluents can cause steel hplc-3components to corrode and form metal complexes that leach onto your column, interact with the stationary phase, and negatively affect peak shape and resolution. Fewer injections can be performed on expensive columns and more time is lost in system maintenance and qualification. Bottom line: your system may be pushing your analysis out of acceptable method specifications, and prematurely rendering your column unsuitable.

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Many labs will passivate their stainless steel HPLC to reduce the amount of metal eluting from their system. This is a tedious and time-consuming process of flushing the entire system with a chelator. In the competitive biopharmaceutical industry, every minute and every dollar spent to create product counts. The more time spent on system maintenance, rework, and consumables, the more your process costs.

The Biocompatible System Solution

We recognize labs do not want to deal with the struggle of short column lifetimes, constant passivation, and surface binding of biomolecules to a steel system. Analyzing biopharmaceuticals is challenging enough, so we removed as much complication as possible with the introduction of fully biocompatible Thermo Scientific™ Vanquish™ UHPLC systems that were built for biopharma. The entire flow-path on Vanquish Horizon and Vanquish Flex systems contains bio-inert materials including: MP35N, titanium, ceramic, sapphire, PEEK, UHMW polyethylene, and fluoropolymers — delivering superior analytical quality and robustness for therapeutic proteins. Thermo Fisher Scientific works hard to understand your challenges and deliver cutting edge solutions. Visit the links below for more information on Thermo Scientific’s biocompatible LC offerings.

 

Be sure to also explore Thermo Scientific’s full charge variant profiling workflow. Visit Meeting your needs for robust charge variant profiling.