1. Guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products;International Conference on Harmonisation;Notice. Food and Drug Administration, HHS, Fed Regist,1999
2. Host-cell protein measurement and control;Wang;Biopharm International,2015
3. Risk Assessments and Control Strategies for Host Cell Proteins, CMC Strategy Forum;Graham,2015
4. Defining your product profile and maintaining control over it, part 2: challenges of monitoring host cell protein impurities;Champion;Bioprocess Int.,2005
5. Host cell proteins in biologics development: identification, quantitation and risk assessment;Wang;Biotechnol. Bioeng.,2009