Webinar: Removing The Barriers To Cell Therapy Manufacturing with GMP-grade Solutions

Speaker:

Dr. Anil Kumar (PhD), Head of CMC in Europe

At ACROBiosystems, Dr. Anil Kumar spearheads the team's initiatives of raising awareness and promoting advanced GMP grade solutions for clinical manufacturing of cell and gene therapies. With a PhD in Protein Engineering and over a decade of experience in biopharmaceutical research and development, Anil has been instrumental in leading teams and advancing therapeutic modalities for immune-oncology and auto-immune indications. Prior to joining ACROBiosystems, Anil served as the Director of Antibody Discovery and Protein Engineering at ImmunOs Therapeutics AG. During his tenure, his team played a pivotal role in advancing therapeutic modalities targeting solid tumors, notably placing the lead biologic candidate IOS-1002 for clinical development.

This online symposium will explore:

• - Cell and gene therapy manufacturing regulations

• - Qualification  of raw & ancillary products

• - Safety controls and reliability evaluations

• - Solutions towards product quality enhancement

Abstract:

Cytokines and growth factors are integral to cell therapy manufacturing, facilitating cell reproduction and differentiation crucial for producing advanced therapeutic medicines. With the rise of immune cell therapies like CAR-T/NK cells, there is a growing interest in ensuring quality management within the industry.

As the industry shifts focus to ensuring manufacturing consistency and quality, rigorous quality control measures are necessary not only for final therapeutics but also for raw and ancillary materials. This necessitates exploring key methods and new assay validation procedures in GMP product development to ensure safe raw materials for therapeutic manufacturing.

ACROBiosystems develops comprehensive solutions and high-quality reagents crucial for the clinical stages of immune cell therapy drugs. Leveraging the GMP-grade quality management system platform and adhering to the stringent production specifications of cell therapy drugs, we have developed a range of high-quality GMP-grade ancillary products. These products undergo rigorous quality management and drug-level release testing standards, ensuring their safety and efficacy. Our GMP-grade cell therapy reagents are therefore designed to support and expedite clinical research on immune cell therapy drugs, ultimately fast-tracking the global regulatory approvals.