Out with the old, in with the new…
We’re all familiar with the adage, “Out with the old, in with the new,” but we probably tend to think of it as it applies to clothes for donation or past relationships, and maybe not in terms of updating our old laboratory equipment. After attending my first WCBP conference, held in Washington, D.C. during January, and hearing life cycle management and ICH Q12 being discussed with more frequency than the local weather (the city had been hit by a blizzard the day before), my recent work on method transfer to a modern UHPLC system was at the forefront of all of my thoughts.
WCBP is a conference held by the CASSS organization every year, and serves to interface the biotechnology industry and various regulatory agencies around the world. Attending the conference was an opportunity for me to gain greater insight to regulatory standards and to better understand what is required for biopharmaceutical submission approval—from both a regulatory and industry perspective. I was also looking forward to learning about new advances in analytical methodologies and technologies.
ICH Q12 Lifecycle Management is a guideline that promotes continual improvement across the product life cycle and ultimately makes it easier for industry to implement changes and helps the regulatory process to operate more efficiently. Although a hot topic at last year’s conference since its introduction, with a technical document anticipated in 2017, the guidance continues to draw excitement. As more and more pharmaceutical manufacturers incorporate life cycle management into their respective workflows, the ACQUITY Arc System is a modern UHPLC platform that offers seamless integration into existing workflows.
In a series of application notes, I evaluated the method transfer of validated SEC and IEX methods, and a general platform method for peptide mapping. Methods were transferred from an Agilent 1100 HPLC System to an ACQUITY Arc System.
The results from each of these studies showed near identical relative retention times and peak area percentages between the two systems. The ACQUITY Arc System is equipped with Multi-flow path Technology, which not only allows for seamless transfer of legacy HPLC methods, but can also support method updates to UHPLC conditions on the same platform.
In scaling the SEC method from HPLC to UHPLC, there was no difference in the percentage of aggregates, but the result was determined in less time and with better resolution. The changes made to the method are in line with the USP’s allowable adjustments, which avoids the need for method revalidation.
By regulatory agencies supporting life cycle management through their guidances, the pharmaceutical industry can ultimately reap the benefits that new innovations like the ACQUITY Arc provide.
If you would like to learn more about how the ACQUITY Arc System can be integrated into your workflow, please refer to the following application notes: