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Poster Presentations
Day 3, June 24（Tue.）
Room P (Maesato East, Foyer, Ocean Wing)
- 3P-PM-23
HCP Risk Assessment Using MS during Purification Process Changes in Biopharmaceutical Production
(Kyowa Kirin)
oKazutomo Takaishi, Mamoru Yoneda, Akari Hiyama, Yukihito Ohyama, Daisuke Tsuchida
Host cell proteins (HCPs) are impurities from the biopharmaceutical manufacturing process, derived from the host cells used. Problematic HCPs, which exhibit immunogenicity or degrade formulation additives, can impact safety and efficacy. The primary testing method in the industry is ELISA, which quantifies total HCP but does not identify individual problematic HCPs. In contrast, the mass spectrometry (HCP-MS) method is effective for identifying and quantifying specific HCPs. We have developed an analysis method that applies the optimal conditions for our company's products.
HCP-MS test methods are performed under native conditions for enzymatic digestion, which suppresses the digestion of antibodies while only digesting HCP. This makes it easier to detect HCP, which only exists in trace amounts. The peptide supernatant is analyzed using MS, and identification is carried out by matching the data with a database. The results obtained are subjected to certain criteria to produce the final analysis results.
In biopharmaceutical development, the API purification process is changed or revised as necessary, and changes in problematic HCP residues may pose a risk to efficacy and safety. In this study, we analyzed samples from the biopharmaceutical manufacturing process when the purification process was changed and assessed the risk in manufacturing.