CLINICAL TRIAL MATERIALS AND SMALL TO MEDIUM BATCHES

As companies face continual pressure to get products to market quickly, OsoBio stands ready to accommodate your high-value, low- to medium-volume projects that our larger-sized competitors won’t.

OsoBio’s agile size and specialized capabilities – along with our customer-driven work culture – mean that smaller client projects receive the same expert handling and focus on quality assurance and regulatory compliance as larger projects.

We routinely handle nearly every category of sterile liquid, suspended or lyophilized biological or pharmaceutical product, aseptically filled and/or terminally sterilized in small to medium batch sizes.

OsoBio’s clinical trial material and small batch services include:

• Aseptic vial filling
• Lyophilization
• Terminal sterilization
• Emulsion
• Small-batch manufacturing
• Packaging
• Stability storage
• Clinical trial manufacturing for phases I – III

OsoBio’s clinical trials and small to medium batch manufacturing services include:

• Aseptic vial filling
• Lyophilization
• Terminal sterilization
• Emulsion
• Packaging
• Stability storage

Our filling and storage capabilities include:

• three Grade A aseptic filling suites
• 2 cc to 100 cc vials
• volumes ranging from 0.2 mL to 100 mL

ICH Guideline stability storage:

• 2 — 8° C
• -20 — -70° C

OsoBio is making significant capital investments in its manufacturing facilities, including adding a Bosch pre-filled syringe system that is expected be validated and online in late 2012. Read more about our 215,000 square-foot facility and equipment on our facilities page.