Host Cell Protein Profiling in Biopharmaceutical Harvests
Darja Obrstar1, Frieder Kröner2, Bostjan Japelj1
1Novartis Pharma AG , Kolodvorska 27 , SI-1234 Menges , Slovenia.
Analytical Chemistry
|July 27, 2018
Summary
Host cell protein (HCP) impurities in biopharmaceuticals were analyzed using 2-D DIGE. Despite varied manufacturing processes and Chinese hamster ovary (CHO) cell lines, HCP composition remained remarkably consistent.
Area of Science:
- Biopharmaceutical manufacturing
- Protein chemistry
- Analytical biochemistry
Background:
- Biopharmaceuticals often contain residual host cell proteins (HCPs) from production cell lines like Chinese hamster ovary (CHO) cells.
- HCP impurity profiles can be influenced by cell line identity, harvest conditions, and process parameters.
- Characterizing HCPs is crucial for ensuring biopharmaceutical safety and efficacy.
Purpose of the Study:
- To compare the host cell protein (HCP) impurity composition across various Chinese hamster ovary (CHO) cell culture harvests.
- To develop quantitative metrics for assessing HCP composition and its variability.
- To evaluate the impact of diverse manufacturing processes on HCP impurity profiles.
Main Methods:
- Two-dimensional differential gel electrophoresis (2-D DIGE) was employed to analyze HCPs.
- Fifteen null cell culture harvest supernatants from different manufacturing processes and five CHO cell lines were analyzed.
- Numerical metrics were developed for quantitative comparison of HCP composition.
Main Results:
- A high degree of similarity in HCP composition was observed across all 15 analyzed CHO null cell culture harvests.
- Diverse manufacturing processes and CHO cell lines did not significantly alter the overall HCP impurity profile.
- The developed numerical metrics enabled quantitative assessment of HCP composition.
Conclusions:
- The host cell protein (HCP) impurity profile in CHO cell culture harvests is surprisingly consistent, even across a wide range of manufacturing processes.
- This consistency suggests that platform HCP assay standards may be suitable for new products and that process changes have a limited impact on HCP composition.
- Further investigation into the factors influencing HCP variability may refine biopharmaceutical impurity control strategies.
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