COVID-19

Vaccine and Gene Therapy Development

Host Cell Protein Analysis by ELISA and Orthogonal Methods in Vaccine and Gene Therapy Development

Presented by Cygnus Technologies

Speaker: Jared Isaac, Ph.D, Sr. Scientist, Cygnus Technologies LLC

Content

Next generation recombinant vaccines and gene therapy products require clinical and commercial manufacturing of protein antigens and/or viral vectors produced using cell culture technologies. Regulatory guidelines require testing for cell substrate related impurities, media and purification additives as well as adventitious agents throughout vaccine and gene therapy development to study the candidate’s purity, safety, and efficacy. While low levels of most impurities can be inconsequential, patient safety demands that host cell proteins (HCP) be eliminated or reduced to the lowest levels practical. Guidelines used in monoclonal antibody and recombinant protein development such as ELISA monitoring of HCP during purification can be applied. A key step in downstream purification of viral vectors and recombinant vaccines is the selection of a platform HCP ELISA kit or developing a custom HCP ELISA. One part of determining that the ELISA is fit for purpose is performing antibody coverage analysis. In this webinar, we will discuss orthogonal Antibody Affinity Extraction (AAE™) and Mass Spectrometry (MS) methods used to assess ELISA Ab coverage to HCPs present in a process and identify process-specific HCP that may co-purify with a drug substance. Case studies of HEK 293, Sf9 and Vero cell-based processes will be presented.

Key Learning Objectives:

• Understand the importance of HCP analysis in recombinant vaccine and viral vector development

• Learn about the role of HCP Immunoassays and the current orthogonal methods for HCP analysis

• Review case studies demonstrating orthogonal HCP analysis by AAE and MS in HEK293, Sf9, and Vero cell-based processes