Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.

• BACKGROUND. Introduction. ANALYTICAL METHOD. Statistical Methods for Analytical Procedure Development, Validation and Transfer. Parallelism Testing of Bioassay. Validation of Assay Linearity. ROCESS DEVELOPMENT. Residual Host Cell DNA Risk Assessment. Statistical Evaluations of Viral Clearance. Pre-filtration Bio-burden Testing. Process Validation and Verification. MANUFACTURING. Specifications.

Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.

• BACKGROUND. Introduction. ANALYTICAL METHOD. Statistical Methods for Analytical Procedure Development, Validation and Transfer. Parallelism Testing of Bioassay. Validation of Assay Linearity. ROCESS DEVELOPMENT. Residual Host Cell DNA Risk Assessment. Statistical Evaluations of Viral Clearance. Pre-filtration Bio-burden Testing. Process Validation and Verification. MANUFACTURING. Specifications.

Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.

• BACKGROUND. Introduction. ANALYTICAL METHOD. Statistical Methods for Analytical Procedure Development, Validation and Transfer. Parallelism Testing of Bioassay. Validation of Assay Linearity. ROCESS DEVELOPMENT. Residual Host Cell DNA Risk Assessment. Statistical Evaluations of Viral Clearance. Pre-filtration Bio-burden Testing. Process Validation and Verification. MANUFACTURING. Specifications.