Technological innovation and advancements have enabled novel designs for antibody-based products, vaccines, blood products, gene and cell therapy candidates. While mAB conjugates like ADCs and novel mAB constructs like bispecifics molecules have been maturing as approved therapies for unmet medical needs, additional molecules like mAb fragments, trispecifics, cocktails, bifunctional (e.g., mAb-cytokine fusion proteins), and non-IgG isotype molecules are in development. Novel approaches to vaccine design include the expression of antigen to elicit a protective immune response and development of universal vaccines for flu and SARS-CoV-2. Gene and cell therapies continue to evolve, including new designs for CAR-T cell constructs to decrease side effects, improve proliferation and cytotoxicity, and increase specificity of therapeutic targets. The emerging allogenic/ Induced Pluripotent Stem Cells (IPSC) CAR-T cells will further the reach of CAR-T applications. In addition, macrophage CAR which are in development may better target solid tumors. This springs the questions, do novel modalities warrant novel product quality controls because of product quality concerns? It is acknowledged that based on the modality, additional testing based on novel analytical techniques, control and characterization may be recommended and should be determined on an individual case basis. This should be informed by scientific knowledge and risk-based approach aligned with guidance documents. In this session we will discuss the industry’s current trend and application of innovative approaches for new modalities, with a focus on the success, challenges, and lessons learned during product development.

Session Speakers:

Enhanced Quality Attribute Understanding Enabled Accelerated Development of a RSV Vaccine

John Davis, Pfizer, Inc.

Analytical Considerations in the Development of Engineered Therapeutic IgM Antibodies

Devinder Ubhi, IGM Biosciences, Inc.

Jaime Marach, IGM Biosciences, Inc.

6+ Years of Autologous CAR-T Therapy

Mehrshid Alai-Safar, Kite, a Gilead Company

Kavita Aiyer

Appearances