Host Cell Protein Testing: Perspective of Current and Future Techniques

Biologics are produced using living cells or organisms. The living cells can be derived from prokaryotic, eukaryotic, and mammalian cells that are genetically engineered to encode the protein of therapeutic use. During the protein expression process, thousands of endogenous proteins, or host-cell proteins (HCPs), are produced and needed to maintain cellular function and regulation, as well as the protein of interest. In cells, the HCPs have a wide range of functions such as growth, proliferation, survival, gene transcription, and protein synthesis, but they are unwanted impurities in the biologics product. Due to their highly diverse physicochemical characteristics, these HCPs can co-purify with the drug substance, and—despite purification steps meant to remove them from the therapeutic protein of interest—low levels can remain in the final drug product, contaminating it. Good Manufacturing Practices (GMP) require that manufacturers demonstrate that they have cleared drug substances
of residual HCPs to the lowest level possible prior to releasing their drug products. The methodologies for meeting this
challenge are changing rapidly as new instrumentation and techniques are becoming available to laboratories. The following paper outlines the latest developments, focusing on emerging best practices.

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