Biologics, or biological products, can include any type of medical therapy derived from living organisms. Biologics have become an appealing option to develop and use because of their ability to treat a variety of conditions—from rheumatoid arthritis to cancer to Crohn’s disease—more effectively, and with less side effects.
The interest to develop and manufacture biologics has significantly increased in recent years, with biologics becoming one of the fastest growing classes of therapeutic compounds available. According to the FDA, “biologics can be composed of sugars, proteins, or nucleic acids or combinations of these substances, or may be living entities such as cells and tissues.”
Host cell proteins (HCPs) can have a major impact on the development of biologics. HCPs are process-related impurities that are produced by the host organism during biologic manufacturing and production. Any biopharmaceutical going to market must show that HCPs and other process-related impurities are at a low, safe level for patients. If the level of HCPs is too high, it can trigger an adverse immune response in the patient. Although the purification process to identify and remove HCPs is crucial, it can also be challenging.
What methods are used to detect HCPs?
The enzyme-linked immunosorbent assay (ELISA) is considered the gold standard for HCP detection and quantitation. The other benefit to this technique is that with ELISA kits, ELISAs can be performed in standard laboratories, making it an affordable and accessible option. One important consideration associated with ELISA kits is the need for a sufficient supply of reagents. Lab managers should have a plan in place to ensure long-term supply storage and supply of reagents and kits.
Mass spectrometry has become another useful option for HCP analysis, as it effective at detecting a wide range of HCPs and can identify HCPs that ELISAs may miss. However, a mass spectrometer is a more significant investment, making the technique of identifying and analyzing HCPs with mass spectrometry a more expensive option. If labs are capable of doing it, mass spectrometry may be best used as a complimentary technique to ELISA.
Develop a strategy and find the right partner
Regardless of the method, the results of HCP detection and analysis need to be robust and reproducible to meet requirements and industry approval. Look for kit providers who are willing to work with you to address challenges and meet your needs. HCP starts with the right products, but ultimately requires an informed strategy to make it to the next phase of approval.
Contact Cytiva for more information on HCP solutions.