Late-Phase and Commercial Pharmaceutical Manufacturing
OsoBio is committed to serving as your contract manufacturing organization (CMO) of choice for late-phase clinical trials and bringing them to commercialization - especially those that involve biologic, highly potent or controlled compounds.
We routinely handle nearly every category of sterile liquid, suspended or lyophilized biological or pharmaceutical product, aseptically filled and/or terminally sterilized on a commercial-sized scale.
Our specialized capabilities ensure that the smallest of projects receive the same attention and expert handling as larger projects.
OsoBio's commercial manufacturing services include:
- Aseptic vial filling
- Terminal sterilization
- Stability storage
For cGMP production of complex products:
- Highly potent compounds
- DEA controlled sbustances
- Monoclonal antibodies
- Liposomal suspensions
- Nano-sized particles
- Inactivated & attenuated
SPECIAL handling CAPABILITIES:
- Oxygen-Sensitive Parenterals Manufacturing
Oxygen-reduction systems are installed on all filling lines. The system allows OsoBio to apply it to any combination of vial and stopper, and results in 2-5% residual oxygen.
- DEA Controlled Substances Manufacturing
OsoBio has been granted DEA approval for the manufacturing of Schedule II-V controlled substances.
filling and storage capabilities:
- Three Grade A aseptic filling suites
- 1,230 sq. ft. of lyophilization capacity across four lyos
- Two compounding/formaulation areas (four suites)
- 139,000 sq. ft. warehouse space
- Two vial labeling and packaging lines
- ICH guideline cold stability storage
- Microbiology lab to support production 24/7
Learn about our facility and equipment on our facilities page.