Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the fourth part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; 1 Part 2 examined the major differences between biologics and chemical drugs; 2 Part 3 demonstrated that an effective CMC regulatory strategy was possible; 3 and Part 5 will address...

Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; 1 Part 2 examined the major differences between biologics and chemical drugs; 2 and Part 4 will examine the challenge of adventitious agent contamination control for biologics. Failures...