It is not uncommon for Integrity Bio to be asked to handle a not so common request.
Aseptic fill and lyophilization of a suspension formulation that cannot be sterile filtered. Formulation, maintenance of homogenous suspension, filling, lyophilization, and capping were managed under strict aseptic practice.
Fill finish of a temperature sensitive hydrogel formulation. Entire operation needed to be maintained within a narrow temperature range in the aseptic environment.
Fill and lyophilization of a protein therapeutic in the Lyotip, a novel delivery device with a unique design. Customized manufacturing protocol was developed including UF/DF, filling with a syringe filler, lyophilization with Lyotip in trays, capping, and ultrasonic welding.
Development of an efficient lyophilization cycle for a formulation containing excipients that are difficult to lyophilize. Overall drying time has been reduced to less than half of the original cycle.
Fill finish of a formulation containing very low protein concentration and GMP stability studies to support ambient temperature stability.