1. EMA Variations page, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001782.jsp&mid=WC0b01ac0580b18c7b (accessed 04.24.17).
2. ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process, 2004 (ICH documents may be obtained from www.ich.org; click large Q in upper right-hand corner, select Q5A to Q5E to get drop down menu, select Q5E, document may be obtained from icon on right-hand side of page).