Integrity Bio offers cGMP facilities to manufacture sterile lyophilized formulations. The lyophilization facility at Integrity Bio operates under class 100 conditions and is capable of developing, manufacturing, and validating customized lyo cycles. Our lyophilization batch sizes can range from 150 to 5000 vials depending on your required presentation. We can conduct Engineering Runs to monitor assure a smooth transfer or development of your product specific cycles.
In order to increase efficiency, precision, and control of the lyophilization process, Integrity Bio incorporates NIST traceable calibration programs, and robust maintenance programs for all equipment and utilities.
We also provide lyophilization cycle development services with over 30 years of collective cycle development experience.
Talk to us about all your lyophilization needs, if we cannot help you chances are we know who can.