GMP Manufacturing

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Overview

TOT BIOPHARM has established a large-scale commercial GMP production base for biological drugs. It is equipped with multiple complete upstream and downstream production lines, and the total manufacturing capacity has exceeded 20,000 L.

The company has established an integrated platform for antibody-drug conjugates (ADCs), which allows for key production steps such as the antibody, drug substance (DS) and drug product (DP) to be completed in one site, reducing the transfer costs and regulatory risks.

The platform has supported the commercial production of two marketed products.