Global regulations that apply to the control of adventitious agents in raw materials cover prions, viruses, mycoplasma, bacteria and molds/ yeasts. The establishment of a risk assessment concerning these agents should cover the likelihood of contamination, the consequences if a contamination event occurs and the impact on the product safety and availability to the public. The control of adventitious agents include sourcing of raw materials for prions, testing, cleaning/decontamination, filtration, heat, low pH and gamma irradiation for the remaining agents. The efficacy of these modes of control depends on the agent's resistance to physical and chemical inactivation and retention by filters. Many viruses may contaminate the biopharmaceutical processes and each family of viruses possess unique resistance to physical and chemical treatments and retention characteristics with filters, thus one approach will not remove or eliminate all viruses. At least ten virus families have been reported to contaminate CHO cells the workhorse for the biopharmaceutical field and the majority of these contaminations have originated from raw materials. A science based approach based on the characteristics of the adventitious agents should be taken to minimize the risk of contamination by prions, viruses, bacteria, mycoplasma and molds/yeasts. Global regulations, current publications and current PDA technical reports aid in the development of this approach.
展开▼
