Best Practices in HCP Assay Development and Integration of Advanced Orthogonal Methods

Register Free: https://www.biopharminternational.com/bp/integration

Event Overview:

A well-developed and broadly reactive host cell protein (HCP) Enzyme-Linked Immunosorbent Assay (ELISA) is a sensitive and specific method used during the purification process of biologics to ensure removal of HCPs and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require that sponsors use orthogonal methods for demonstrating antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA is fit for purpose.
In this webinar, a Cygnus Technologies expert will discuss:

• Types of HCP immunoassays
• Best practices in HCP immunoassay development
• Common mistakes and misconceptions that can misguide assay developers
• Advanced orthogonal methods of immunoaffinity chromatography and mass spectrometry to fully qualify HCP ELISA and characterize individual HCPs in in-process and drug substance samples

Key Learning Objectives:

• Understand best practices in HCP immunoassay development
• Learn about advanced orthogonal methods for HCP ELISA qualification
• Learn how orthogonal method integration enables data-driven decisions on whether a process-specific assay is necessary and/or superior to a well-developed generic or platform method

Who Should Attend:

• Analytical scientists supporting biologics process development, manufacturing, and quality control
• Process development scientists
• Chemistry, manufacturing, and controls (CMC) departments
• Regulatory consultants
• Regulatory scientists

Speaker

John Locklear
Technical Services Manager
Cygnus Technologies

As a technical services manager, John Locklear leads technical support for Cygnus Technologies customers worldwide. Since joining Cygnus Technologies’ R&D department in 2011, Locklear developed many generic and custom HCP ELISA assays for several mammalian, yeast, and bacterial cell culture platforms as well as several host cell DNA assays. Locklear received a B.S. in biotechnology from the University of North Carolina at Pembroke.

Register Free: https://www.biopharminternational.com/bp/integration