For bio-production of clinical materials, especially monoclonal antibodies and other protein based drugs, we provide a wide range of development and manufacturing services from cell line optimization and process design to full-scale cGMP production, purification and aseptic filling, in addition to corresponding testing, validation, analytical and regulatory support.
Our senior operations management and senior quality systems staff average over 20 years of experience in clinical trials manufacturing of biopharmaceuticals, specifically monoclonal antibodies and recombinant proteins expressed in mammalian cells. We hold ourselves responsible for bio-production of clinical materials under the strictest standards for quality and compliance with federal guidelines.
Our FDA registered cGMP manufacturing facility in Princeton, NJ encompasses 57,000 sq.ft building, including 25,000 sq.ft of manufacturing and support, 15,000 sq.ft of development and 4,000 sq.ft of pilot plant.
Equipment for bio-production of clinical materials includes:
- Hollow-fiber bioreactors
- Stirred-tank bioreactors (20L, 300L and 2500L)
- Wave Bioreactors® (20L, 50L, 200L, 500L)
- Incubators
- Bench top and process scale purification systems (2 LPM, 10 LPM, 30LPM)
- One aseptic vial-filling machine with fully disposable fluid path
- WFI system
- Autoclaves
- Depyrogenation oven
- Vial and stopper washers
- Cold rooms
- Analytical equipment
We constantly validate our critical equipment and processes and our facility is registered with the FDA. We provide quality-driven solutions for clinical trials manufacturing of your monoclonal antibodies or other protein based therapeutic drugs successfully time after time. We have overcome challenges in many clinical trials manufacturing projects resulting in successful outcome.
We invite you to come visit us and get to know us. Contact us for all your needs on bio-production of clinical materials at [email protected]. Our goal is to help you achieve your goals successfully.