GMP Fill / Finish: Integrity Bio is open to the challenge!

Integrity Bio has two fill finish lines. Our first line opened in 2009 and can handle 2cc to 50cc vials. This line can handle 6,000 vials or 10,000 prefilled syringes per run. It not only harnesses a disposable technology, it can also perform lyophilization. The second line opened in 2020 and is a fully automated, modern RABS system that has over twice the capacity as our first line. Line 2 can only handle liquids; lyophilization is not possible.

It is not uncommon for Integrity Bio to be asked to handle a not so common request.

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 a formulation containing excipients that are difficult to lyophilize. Overall drying time has been reduced to less than half of the original cycle.

5

Fill finish of a formulation containing very low protein concentration and GMP stability studies to support ambient temperature stability.