Aragen's Validation Journey with Getinge's SUPR Single-Use Bioreactors

Aragen's Validation Journey with Getinge's SUPR Single-Use Bioreactors

Aragen Bioscience, located in Morgan Hill, California, is the biologics discovery and early development subsidiary of Aragen Life Sciences. The Morgan Hill campus supports cell line development (CLD), process development (PD), bioproduction, antibody discovery, and analytical characterization of therapeutic and diagnostic antibodies and other biologics for human and animal health.

In its work, Aragen uses Getinge's Applikon 2 L, 5 L, and 10 L glass stirred-tank (multi-use) bioreactors to support their client research and development (R&D) programs. Larger-scale production runs needed for preclinical efficacy and toxicology studies were not feasible. As a trial, Getinge offered 50 L and 250 L single-use production reactors (SUPRs) that would allow Aragen to produce larger volumes for preclinical production.

Getinge's SUPRs are targeted to any production where 50 L or 250 L is a normal production run. The 50 L and 250 L SUPRs increase efficiency, eliminating the clean-in-place (CIP) and sterilization-in-place (SIP), while significantly reducing the risk of contamination. They are GMP compliant, which is useful for companies working on clinical trials, where larger quantities of cells are needed quickly.

Aragen's goal for this study was to see if their production process - developed using their Getinge Applikon 2 L, 5 L, and 10 L glass stirred-tank reactors (STRs) - could be easily scaled up to larger, single-use bioreactors. Getinge was interested in obtaining customer data for the 50 L and 250 L SUPRs. Thus, Aragen's partnership with Getinge was born.