1. World Health Organization (WHO) Regulatory Risk Assessment in the Case of Adventitious Agent Finding in a Marketed Vaccine: Scientific Principles to Consider (2013);
www.who.int/biologicals/WHO_Risk_Assessment_1st_public_consultation_12_March_2013.pdf
2. ICH Q9 Quality Risk Management (November 2005);
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
3. Centers for Disease Control and Prevention (CDC): Prion Diseases; CDC website,
www.cdc.gov/prions/index.html
4. Wickner, R.B., Yeast and Fungal Proteins, Cold Spring Harb Perspect Biol (2016);
pdfs.semanticscholar.org/550a/dcd7c90ba03f47b05b6d108ed0eb879fa565.pdf
5. FDA Drugs: Celebrating a Milestone: FDA’s Approval of First Genetically-Engineered Product (2007);
www.fda.gov/downloads/aboutfda/history/productregulation/ucm593496.pdf