Validation of Potency Bioassays for Biologicals
Category: Drugs and Chemicals (Pharma) , Biotechnology , FDA Validation , Testing and Validation , Biologics and Biosimilars , Life Sciences

Validation of Bioanalytical Assays for Biologicals
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Biologics and Biosimilars , Life Sciences

Validation of Immunogenicity Assays for Biologicals
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , FDA Validation , Testing and Validation , Biologics and Biosimilars , Life Sciences

Accelerating Bioassay Transfer in a GMP Environment
Category: Drugs and Chemicals (Pharma) , Energy & Utility , Biotechnology , All FDA Regulated Industry , Technologies and Processes , Blood and Blood Products , Biologics and Biosimilars , Best Practices & GXPs , Life Sciences

Effective Method Transfer of Complex Bioassays
Category: Drugs and Chemicals (Pharma) , Biotechnology , All FDA Regulated Industry , Biologics and Biosimilars , Life Sciences

Implementation of the USP GMP Potency Bioassay Suite
Category: Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Quality & Safety , Technologies and Processes , Biotech Regulations , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations

Managing Immunogenicity Risk in Biopharmaceuticals
Category: Drugs and Chemicals (Pharma) , Biotechnology , Quality & Safety , Technologies and Processes , Life Sciences

Life Cycle Validation of GMP Potency Bioassays
Category: Biotechnology , All FDA Regulated Industry , Quality & Safety , Blood and Blood Products , Biologics and Biosimilars , Best Practices & GXPs , Life Sciences

Recommendations for Cell Banks used in GXP testing
Category: Biotechnology , Biotechnology , Testing and Validation , Quality & Safety , Cellular and Gene Therapy , Life Sciences