Host Cell Protein Testing: Ensuring Biopharmaceutical Safety and Quality
In the rapidly growing field of biopharmaceuticals, ensuring the safety and purity of therapeutic proteins is a critical challenge. One of the key aspects of maintaining product integrity is monitoring residual host cell proteins (HCPs), which are unintended proteins produced by the host cells used in biologic drug production. Host Cell Protein Testing plays a pivotal role in confirming that these contaminants are minimized to safe levels, safeguarding patient health and maintaining regulatory compliance.
HCPs can originate from various cellular processes in the host organism, such as protein expression, metabolism, or cell lysis during manufacturing. Even trace amounts of these proteins in the final therapeutic product can potentially cause immunogenic responses in patients or interfere with the drug’s efficacy. Therefore, identifying and quantifying HCPs is essential at multiple stages of production, from upstream processes like cell culture to downstream purification and…