FDC Biotech Manufacturing Center
ADC conjugation Expertise.
At FDC Biotech, our in-house GMP pilot manufacturing center is the backbone of our innovative ADC (Antibody-Drug Conjugate) development. Designed to meet global regulatory standards, we deliver high-quality, scalable production from antibody conjugation to final drug product.
Key Capabilities
Fully compliant with GMP regulations, ensuring robust quality control and traceability.
Grade B/C cleanrooms and validated processes for sterile production.
In-house conjugation expertise: From antibody conditioning to linker-payload coupling. We optimize DAR (Drug-to-Antibody Ratio) and stability.
State-of-the-art analytics: HPLC, LC-MS, and SEC for purity, aggregation, and DAR characterization. Stability studies: Real-time and accelerated testing to ensure shelf-life and compliance.
