(1) 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.
(2) Fill finish of a temperature sensitive hydrogel formulation. Entire operation needed to be maintained within a narrow temperature range in the aseptic environment.
(3) 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.
(4) Development of an efficient lyophilization cycle for aformulation containing excipients that are difficult to lyophilize. Overall drying time has been reduced to less than half of the original cycle.
(5) Routine fill finish of vials sizes ranging from 2 cc to 50cc up to 6,000 units per batch or prefilled syringes up to 10,000 units per batch
(6) Fill finish of a formulation containing very low protein concentration and GMP stability studies to support ambient temperature stability