CDMO

CDMO Partnership

Penn Life Sciences has allotted a portion of the capacity to offer CDMO partnership on a case-by-case basis.

The following technology is available for CDMO partnering:

• Load cell monitored Stainless Steel 316L jacketed vessels with bottom mount, magnetically coupled impellers
• Tank mounted “real time” in process monitoring of dissolved oxygen, pH, conductivity and product temperature
• All vessels have sterile sample ports allowing for bulk bioburden testing.
• The manufacturing line has a recirculation loop on the surge vessel for filling suspensions.
• Temperature control +/- 1°C with preset ramp rates and temperature profile programs
• 225 ft³ IMA Life custom-built Lyophilizer with automatic loading and unloading plus capacity for up to 90k vials at a time
• Nitrogen sparging and headspace flushing capability for all vessels
• Low shear and high shear (rotor/stator) permanent bottom mount mixers with RPM range from 8RPM to 3,200RPM provides capability for the manufacture of gels, suspensions and emulsions
• The ability to maintain 2°C-8°C temperature during compounding and filling
• Pre and post product fill nitrogen flush can provide down to 0.5% oxygen head space levels
• Two 5 liters SS pilot scale tanks identical to the production scale for formulation trials