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
• Lyophilization
• Terminal sterilization
• Emulsion
• Packaging
• Stability storage

For cGMP production of complex products:

• Highly potent compounds
• DEA controlled sbustances
• Cytotoxics
• Proteins/peptides
• Monoclonal antibodies
• Liposomal suspensions
• Nano-sized particles
• Inactivated & attenuated
  live vaccines

 

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
• 2 cc to 100 cc vials
• volumes ranging from 0.2 mL to 100 mL
• learn about our new filling suite
• 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
• 2 – 8° C
• -20 – -70° C
• Microbiology lab to support production 24/7

Learn about our facility and equipment on our facilities page.