SP Scientific is supplying AAIPharma Services with equipment to boost its lyophilisation development and optimisation capabilities.
SP will supply AAIPharma with a LyoStar 3 pilot-scale lyophiliser paired with a complementing Hull production-scale lyophiliser, both equipped with Praxair’s ControLyo Nucleation On-Demand Technology.
“By procuring both the pilot-scale and production scale lyophilisers with ControLyo technology, AAIPharma significantly enhances its lyophilisation development and optimisation capabilities while dramatically increasing our scalability and total lyophilization capacity,” said James Fife, senior director of parenteral operations at AAIPharma.
“Cycles will be developed on site in the LyoStar 3 and easily transferred to the production-scale dryer,” Fife added.
ControLyo Nucleation On-Demand Technology allows the user to control the nucleation temperature during freezing and ensure that all vials nucleate simultaneously. Benefits of controlled nucleation including improved vial-to-vial homogeneity, reduced primary drying times, improved cake appearance, reduction in vial breakage and better stability for many protein based formulations.
William Downs, president and CEO of SP Industries, said: “ControLyo technology is the most significant advancement in freeze drying in perhaps decades. It is rapidly being adopted by the industry and those that hesitate to utilise the technology run a real risk of being left behind in a competitive marketplace.”
The pilot-scale lyophiliser will be fully validated and operating within AAIPharma’s cGMP facility by February, 2014. The production scale lyophiliser is scheduled to come online in late 2014.