Scientists from Merck, Novilytic Discuss Pharma Analysis at HPLC 2024
On Monday, July 22, at the 52nd International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC 2024) conference in Denver, Colorado, researchers from industry presented on pharmaceutical analysis using a variety of different chromatography techniques.
Separation science can be used to analyze finished drug products and ingredients quantitatively and qualitatively during the manufacturing process. This is achieved through the separation, quantification and identification of components in a mixture and can be used to reveal the identity of a drug and monitor the progress of a therapy on a disease (1).
The 2024 HPLC conference features a variety of sessions on pharmaceutical analysis and more. Below, you’ll find an overview of some recent research presented by experts at the conference earlier this week.
Chromatographic Appraisal of Monoclonal Antibody Performance
Molecular model of antibody taking part in immune defense. © Dr_Microbe - stock.adobe.com
mAbs are laboratory-made proteins that act like antibodies, seeking out antigens (foreign materials) in the body and working to destroy them. Laboratory-made mAbs can stimulate the immune system (2). Therapeutic monoclonal antibodies (mAbs) are genetically engineered to attack disease-bearing cells. Various therapeutic mAbs, such as zenocutumab and tarlatamab, have been used to treat diseases like lung cancer. There are several mAbs currently in the pipeline to be approved (3).
In the first presentation from this session, F. E. Regnier of Novilytic, a molecular recognition company located in West Lafayette, Indiana, spoke about therapeutic performance appraisal (TPA) assays, based on mobile affinity selection chromatography (MASC), which recognize affinity code monoclonal antibody (mAb) structural features of mAbs that attack cancer cells. Coding the TPA assays was achieved with affinity selectors equivalent to those in patients.
Regnier discussed a new method using therapeutic performance appraisal (TPA) assays based on mobile affinity selection chromatography (MASC) that has been developed to recognize and code the structural features of these mAbs. This coding involves using affinity selectors like those found in patients. The TPA assays execute sample preparation, mAb coding reactions, and proteoform complex resolution in a single MASC sizing column with a 300 Å pore diameter.
Dual-Gradient Unified Chromatography: The Blueprint for Versatility in Simultaneous Multicomponent Analysis
Generality in analytical chemistry is evident in innovative platforms that enhance modern organic synthesis and biopharmaceutical processes. In this presentation, led by Erik L. Regalado from Merck Research Laboratories in Rahway, NJ, spoke about a hybrid separation technique called dual-gradient unified chromatography (DGUC), which is built upon an automated dynamic modulation of CO2, organic modifier, and water blends with various buffers.
DGUC allows simultaneous multicomponent analysis of small and large molecules across a wide polarity range within single experimental runs, utilizing UC/hydrophilic interaction liquid chromatography (HILIC)-like mobile phases in supercritical fluid chromatography (SFC). The scientists developed a DGUC-diode array detector–tandem mass spectrometry (DGUC-DAD-MS) screening workflow, combining multiple orthogonal column and mobile phase choices for a comprehensive elution profile. This framework could aid academic and industrial laboratories in developing new pharmaceutical targets, such as synthetic intermediates, nucleosides, peptides, proteins, and antibody-drug conjugates.
References
- Rees, V. How is Liquid Chromatography Used in the Pharmaceutical Industry? Russell Publishing Limited 2020. https://www.europeanpharmaceuticalreview.com/article/116263/how-is-liquid-chromatography-used-in-the-pharmaceutical-industry/ (accessed 2024-7-22)
- Monoclonal Antibodies. Cleveland Clinic 2024. https://my.clevelandclinic.org/health/treatments/22246-monoclonal-antibodies (accessed 2024-7-22)
- Antibody Therapeutics Approved or in Regulatory Review in the EU or US. Scicomvisuals 2024. https://www.antibodysociety.org/resources/approved-antibodies/ (accessed 2024-7-22)
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Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.
