Osobio Facilities

As a mid-sized manufacturing facility, OsoBio offers flexibility in meeting a range of unique product demands, from clinical to commercial batch sizes to complex potent compounds. With the capability of providing round-the-clock production services, OsoBio is committed to meeting your most aggressive timeline.

Our 215,000 sq. ft. facilities include:

• Two compounding / formulation areas (four suites)
  
• Three Grade A aseptic filling suites
  
• 2 cc to 100 cc vial filling
  
  • Two TL 8 head filling machines (continuous glass supply)
    
  • A TL 4 head filling machine (batched glass supply)
    
• Two vial labeling and packaging lines
  
• Approximately 1,230 sq. ft. of lyophilization capacity
  (Lyos: 410, 410, 300, 108 sq. ft.)
  
• 130,000 sq. ft. warehouse space
  
  • ICH guideline and DEA compliant
  • 10,000 sq. ft. ambient storage
  • 2° – 8° C cold storage (7,000 sq. ft.)
    
  • -20° – -70° C storage

Inspection, labeling and packaging equipment:

• Inspection: two Pace + 100% Inspection
  
• Two Weiler labeling machines
  
• Two Bosch and one Jones cartoners

OsoBio’s campus also includes Sterile University, a fully-equipped manufactuing suite that allows for training and continuing education without exposing the sterile core or interrupting normal manufacturing.

Recent Facility Updates

OsoBio has invested in infrastructural and equipment upgrades that includes a new Grade A aseptic rolling diaphragm pump fill suite for liquid and lyophilized products.

Manufactured by Bosch, the fill suite functions at 115-percent of our previous capacity. The new line offers clients these key benefits:

• Greater precision and yield – thanks to our ability to conduct non-destructive online weight checks, increasing overall yield.
• Heightened safety and security – because of a new restricted access barrier system that minimizes the risk of cross-contamination and diminishes potential occupational exposure.
• Minimal regulatory filing – products with Prior Approval should meet FDA comparability protocols, requiring only the submission of a PAS.

The new line produces sterile liquid, suspension and lyophilized formulations in vials ranging from 2cc to 100cc.

We are proud to bring on the following Bosch equipment:

• An RRU 3084/44 high-performance container washing machine, which uses intensive flooding, ultrasonic and spraying techniques to reliably clean vials inside and out in a continuous process.
• An HQL 4480S drying and sterilization tunnel with laminar flow for depyrogenization and cooling of glass vials.
• An FLC 3080 filling and closing machine that is designed to fill, sample check-weigh and stopper vials in a continuous motion process in compliance with DIN/ISO standards.
• A GLT 4040 tray loader with 100-percent vial counting accuracy.
• A TRL 1030 tray loader designed to automatically load vials at high speed in cleanroom applications, requiring minimal interaction and maintaining GMP practices.

In order to add the new line, OsoBio has extensively remodeled its facility, making these infrastructural improvements:

• Welded PVC walls – installed throughout controlled and classified areas to further enhance the sterile environment and improve durability, ease of use and maintenance.
• Poured-epoxy floors – installed throughout the facility to additional support OsoBio's strong record of industrial safety.