Drug Development & Manufacturing

Effectively managing potent compounds for OsoBio clients

As a contract manufacturing organization that focuses on biologic and pharmaceutical injectable finished drug products — sterile liquid, liquid suspension and lyophilized formulations — OsoBio has demonstrated its ability to safely handle almost any category of product, from clinical to commercial scale.

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

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)

Because of OsoBio’s scientific expertise and industry leadership in potent products, our company has been working closely with ISPE to develop new worldwide standards in effectively managing potent compounds. We look forward to sharing more details about these exciting developments soon.