Biologics 2000 - Comparability of Biotechnology Products: Hyatt Washington Hotel, Washington, D. C., June 2000, Vol. 109 Book

	The Product Development Continuum: the Evolution and Application of the Concept of Comparability	3
	A Global View of Comparability Concepts	9
	Immunogenicity: Concepts/Issues/Concerns	15
	Regulatory and Industry Panel: Perspectives on Comparability. A Global View	25
	Perspective on Assessing Comparability of Biotechnology Products - A View from Japan	27
	A Canadian Perspective on Assessing Comparability of Biotechnology Products	41
	European Industry Position (EFPIA)	49
	Strategies for Demonstrating Comparability	51
	Regulatory Philosophy for Comparability Protocols	53
	Immunogenicity	57
	Challenges with Current Technology for the Detection, Measurement and Characterization of Antibodies against Biological Therapeutics	59
	Use of Biosensors to Monitor the Immune Response	71
	Experience Measuring Antibodies to both Drug and Impurities and their Clinical Sequelae	79
	From Characterization of Antibodies to Prediction of Immunogenicity	87
	Clinical Immunogenicity: Occurrence and Impacts - Industry Experience	97
	Enbrel (Etanercept)	99
	Immune Responses to Recombinant Factor IX (BeneFIX) and Recombinant B Domain Deleted Factor VIII (ReFacto)	103
	The Use of an Animal Immunogenicity Model in the Development of Protropin Somatrem (Methionyl Human Growth Hormone)	107
	Chemistry/Manufacturing/Controls (CMC)	119
	Viral Safety and Clearance Evaluation - Implications for Process Change and Comparability	121
	Detection and Consequences of Recombinant Protein Isoforms: Implications for Biological Potency	127
	Closing Remarks	135
	The Pharmacopoeial Perspective in Accelerating the Development and Availability of Biologicals and Biotechnological-derived Products	137