Aseptic Lyophilization

Bioserv offers custom contract aseptic lyophilization services. Our large, multi-shelf aseptic 48 cubic foot HULL-48 lyophilization equipment is located in our Class 100 (Class 5 or Class A) aseptic suite and supports pilot scale through phase 2 clinical trial production quantities. In addition, Bioserv’s highly skilled lyophilization service technicians are trained to provide guidance with process development issues such as recommending methods for improving ways to remove water from the product to help maximize reconstitution time; collaborating with the client to determine the best way to minimize lyophilization cycle times so that better product stability is achieved which is an important requirement for producing the highest quality lyophilized product. Bioserv’s advanced computer controlled, fully programmable lyophilization software system has gone through rigorous cGMP calibration, maintenance, and validation to ensure that a quality reproducible product is made each and every time. .Bioserv offers a unique commitment to its clients and that commitment is to produce the highest quality lyophilized drug product on time or ahead of schedule.

The HULL-48 can accommodate containers ranging from 2mL vials to 100mL bottles with batch sizes ranging from a few hundred vials up to 10,000 vials.