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  • Feature ArticlesFeature Articles

    Demystifying CMC Regulatory Strategy for Biologics - Part 4: Challenges of Adventitious Agent Control

    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...
  • Feature ArticlesFeature Articles

    Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible

    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...