Abzena ltd

Bioconjugate Manufacturing

Non-GMP Manufacturing

• Non-GMP batches for GLP toxicology studies
• Experienced team of process and analytical chemists
• Scale: Up to 100g of toxin-linker – 50g antibody/protein drug conjugate

GMP Manufacturing

• Dedicated cGMP analytical lab and knowledgeable, analytical chemists
• Analytical lab equipped with highly sensitive instruments for trace level analysis of cytotoxic compounds
• Well-equipped and newly upgraded laboratories
• Glovebox isolators for weighing cytotoxins and to carry out processes
• Large-scale purification equipment
• Quality system and documentation in compliance with CFR guidelines
• In-process and final product analyses and validated test methods
• Upgraded facility to ensure smooth material and personnel flow
• Documented procedures to receive raw material and disposition
• Well established controls (engineering, administrative, and PPE controls) for handling cytotoxic materials
• In-house real-time OEL testing to ensure high-level safety for personnel and environment
• Scale: 20–100 g based on process