Quantitation of Poloxamer P188 in Biopharmaceutical Formulations Using Charged Aerosol Detection

High performance liquid chromatography (HPLC) is a commonly used technique in the pharmaceutical research and manufacturing sectors to determine the concentration and purity of active pharmaceutical ingredients (APIs) or to measure process related residuals and formulation components. In biopharmaceuticals manufacturing or formulation, polysorbates or poloxamers are commonly present either as process related residuals or as formulation components.

The detection and quantitation of these compounds can be a challenge due to their lack of a chromophore which makes traditional UV detection impossible and interference from proteinaceous APIs. This presentation reviews the development and validation strategies of a robust method for the quantitation of poloxamer P188 in biopharmaceuticals. The method uses charged aerosol detection (CAD) on the Thermo Vanquish Flex HPLC system and has suitable sensitivity to quantitate poloxamer P188 down to 3 µg/mL in both AAV and mAb APIs.

The method is specific in that it is capable of quantitating poloxamer P188 in common formulations and demonstrates non-interference from polysorbate-80 and PEI.

Join our webinar on Tuesday, July 11th at 15:00 CEST (14:00 GMT, 06:00 PDT, 09:00 EDT) to hear about the work of our guest speaker, Adam Punke, from PPD, Part of Thermo Fisher Scientific. In his presentation, he will share his experience of the development and validation strategies of a robust method for the quantitation of poloxamer P188 in biopharmaceuticals.

Learning points:

• What makes charged aerosol detection so powerful
• What benefits it offers
• What applications are ideal for charged aerosol detection?

Who should attend:

• Laboratory managers and directors
• Technology leaders
• Principal scientists
• Laboratory analysts

Presenter: Adam Punke (Guest Speaker, Sr. Research Scientist, PPD, Part of Thermo Fisher Scientific)

Presenter: Chris Tuczemskyi (Moderator, Product Marketing Manager, Thermo Fisher Scientific)

Chris Tuczemskyi is a chromatography specialist at Thermo Fisher Scientific, based in Cambridge, UK. After spending a number of years building up his experience with chromatography instruments in a water testing laboratory, he joined Thermo Fisher Scientific in 2014 as a chromatography service engineer for Unity Lab Services. Here he developed his passion for supporting customers using HPLC and in 2018 moved into the application specialist team. More recently, in 2022 he made the move to Product Marketing to help ensure we meet and exceed our customers expectation. In 2009, Chris graduated from the University of Essex in Biochemistry (Bsc Hons).

Presenter: Ian Acworth (Analytical Instruments Group, Thermo Fisher Scientific)

Ian Acworth is part of the marketing team at Thermo Fisher Scientific, based near Boston, Massachusetts. He directed application chemistry development for several HPLC companies while ensuring a strong focus on customer needs and support. He was part of the team that developed and supported the Charged Aerosol Detector. Ian completed his D. Phil in biochemistry at Oxford University in 1986 and completed his postdoctoral studies in neuroscience at MIT in 1989.

Presenter: Frank Steiner (Senior Manager of Product Applications, Thermo Fisher Scientific)

Frank Steiner is Senior Manager of Product Applications and coordinates HPLC based scientific collaborations in Thermo Fisher Scientific as scientific advisor. He joined Dionex Corporation in 2005, now a part of Thermo Fisher Scientific, and had been manager in various HPLC marketing functions. Frank received his PhD degree in chemistry in 1995 from Saarland University in Saarbruecken, Germany where he became assistant professor in 1997 and associate professor in 2003, after his postdoc at the nuclear research center in Saclay, France in 1996. Frank published more than 30 publications in refereed journals and more than 10 text book chapters on HPLC topics.

Presenter: Katherine Lovejoy (Product Application Specialist, Thermo Fisher Scientific)

Katherine Lovejoy, Ph.D., has been an application chemist focusing on charged aerosol detection at the Thermo Fisher Scientific HPLC factory site since 2016 and has a Ph.D. in inorganic chemistry from the Massachusetts Institute of Technology. She has experience as a chemist reviewer at the FDA and as a scientist at Los Alamos National Laboratory.