Abzena ltd

Bioconjugation Process Development and Scale-up

Abzena carries out its bioconjugation process development and scale-up at its dedicated chemistry facility in Bristol, PA, USA. An experienced team of process, analytical and manufacturing chemists carry out the manufacturing in an upgraded facility with well-established controls (engineering, administrative, and PPE controls) for handling cytotoxic materials.

Abzena experience includes:

• Route design and optimisation
• Process optimisation, process impurities and analytical development
• Worldwide sourcing and QC for best quality and cost
• Non-GMP batches for GLP toxicology studies
• Analytical method development for cGMP manufacture
• Preparation of batch records and flow charts
• Tech transfer for cGMP manufacture
• Scale: 50–100 g based on process

Equipment

20-L jacketed glass reactors20-L rotary evaporatorHigh-pressure autoclaves