Biopharmaceutical Method Transfer in Regulated Environments

Discover why speed and resolution is key

Kevin McCowen is an Associate Scientist working for Ajinomoto Althea, Inc. (Althea), a contract development and manufacturing organization providing process development, drug substance manufacturing and drug product manufacturing. In particular, Althea works in a highly regulated environment with oversight from multiple regulatory bodies, including the US Food and Drug Administration (FDA). Kevin is currently working on the method transfer of an amino acid analysis; attempting to speed up this process while maintaining data quality.

“As a contract lab, particularly in biopharmaceutical development, speed is always important”, Kevin explained. However, data quality can never be sacrificed for the sake of speed. Data quality is particularly important in regulatory analysis as “we need to analyze samples that are pulled in-process during a manufacturing run and sometimes the next step of that process relies on the analytical results.”

The power of UHPLC

“Although initially it was seen as a way to achieve the same thing as HPLC but faster, over the past few years, I think UHPLC has taken on a life of its own”, Kevin revealed. As technology such as fluidics and connections have improved, “it’s become faster and more efficient and robust, resulting in lessened peak broadening, leading to better resolution.” Improvements in technology allow his team at Althea to “provide the best information to clients possible through all phases of their product development.” UHPLC also provides greater cost-savings and a lessened environmental impact – “At Althea, we’ve become increasingly more aware of our environmental stewardship and have been implementing improvements to lessen the impact as much as possible. UHPLC, with shorter run times and smaller diameter columns, uses significantly less solvent than traditional HPLC”, Kevin explained.

“Recently, the opportunity came up to work on a collaboration with Thermo Fisher Scientific, using the Thermo Scientific™ Vanquish™ UHPLC System. These types of collaborations give us the chance to expand what we can offer clients, working with the people who built the Vanquish System and using it every day to develop novel solutions to challenging problems. We’re still in the early stages of testing the complete capabilities of the system, but we’ve been really happy with the decrease in analysis time and better resolution we’ve been able to achieve already”, Kevin said. He explained that the integrated modularity of the Vanquish, “the flexibility in configurations, and stackability of detectors” makes the instrument ideal for labs where space is limited.

“We aren’t necessarily a high-throughput lab”, Kevin explained, but the number of plates analyzed can be increased significantly with Thermo Scientific™ Vanquish™ Charger module. The lab is still exploring just what the instrument can do, but Kevin is sure it will only benefit their separations. “I think the two modes of column temperature control will allow more flexibility in the development of separations for intact proteins and make for more consistent transfers of existing HPLC methods to UHPLC”. Kevin also commented that the instrument was obviously designed for the lab operator and not just technically to be the best instrument on the market.

Technology improving results

Developing the instrumentation and incorporating features such as pre-column compression to improve consistency of analyte retention throughout the column will allow results to continue to improve. Kevin explained, “I think that future developments will be in column technologies and chromatography data management. The upgrade to Chromeleon to allow handling of MS data is very helpful, and increasing throughput will require a more sophisticated data management system to handle faster data collection.”

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