Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.

Main activities

• Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
• All fully cGMP and SHE compliant

Features

• Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
• Semi-automated and automated visual inspection
• Automated packaging with digital data visual verification
• Stability study services
• Drug delivery
• Laboratory services
• Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
• Clinical manufacturing (batch sizes less than 5 K units)

Strategic importance

• CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
• Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries