From cell banking to supply to the clinics
At the heart of our Contract Development and Manufacturing Organization (CDMO) are highly skilled professionals whose expertise and dedication enable the manufacturing of complex protein products, live biotherapeutic products and pDNA. We understand the unique challenges and intricacies involved in producing these products and therefore focus on developing robust processes to ensure optimal outcomes in a GMP environment. Our GMP manufacturing services span the complete cycle for biologics, from cell banking to supply to the clinics.
GMP biologics drug substance cleanrooms
- Human IMP licensed manufacturing facility (FAHMP)
- Grade C suites, ISO 5/7 cleanrooms
- Cutting-edge technologies and methodologies to enhance the efficiency and reliability of manufacturing processes
- Environmental monitoring program
Buffer preparation
- As part of end-to-end projects or as stand-alone activity
- Dedicated suites for buffer preparation
- Rapid turnaround to meet tight timelines
- Custom formulations
- From small buffer volumes to productions up to 200L/batch
- In-house QC testing (pH, conductivity, osmolality, endotoxin testing, bioburden testing, visual inspection)
USP/DSP manufacturing activities
- State-of-the art, qualified manufacturing and QC equipment
- Segregated suites for cell culture and fermentation (BSL-2)
- Microbial capabilities: 50L single-use bioreactor
- Mammalian capabilities: 10-50L single-use bioreactor and 200L single-use bioreactor
- Cell banking services including storage (-80°C, vapor phase of liquid nitrogen)
- Flexible chromatography equipment and TFF systems to meet requirements from small to large batches
- Extensive analytical toolbox for IPC, release and characterization testing (insert link to QC testing)
- Storage of bulk drug substance (2-8°C, -20°C, -80°C)
- Smooth transfer to drug product sites for sterile fill & finish or non-sterile manufacturing
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