POTENT and cytotoxic COMPOUNDS

As a first adopter of new international cross-containment guidelines recommended by ISPE (Risk-MaPP), OsoBio expertly manages the risks posed by potent and cytotoxic compounds and DEA scheduled substances, successfully balancing the need for product quality and operator safety.

Because of our expertise in complex and difficult products, OsoBio works with nearly every category* of biological or pharmaceutical agent – and continually produces excellent regulatory compliance and quality assurance results.

OsoBio can manufacture category 1 through 5 products based on the Merck categorization system. Our scientists excel in handling difficult and complex products, especially

• Potent compounds
• Proteins
• Cytotoxic compounds
• Monoclonal antibodies
• Controlled substances

OsoBio's commercial manufacturing services include:

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

Some of the safety and containment measures OsoBio has in place include:

• Dedicated and disposable equipment
• Engineering controls (including air handling units, HEPA filtration, pressure differentials and others)
• Closed processes
• Closed transfer processes
• Closed bag system
• Validated cleaning procedures
• Sanitization and decontamination procedures
• Manual redundant verification
• Electronic redundant verification
• Product testing
• Standard operating procedures
• Master batch records
• Visual inspection
• Separation by time (campaign)

Learn about our facility and equipment on our facilities page.

*does not include beta–lactams or vaccines derived from live organisms