SP Scientific and AAIPharma Services Corp. have entered into a purchase agreement where SP will supply AAIPharma with a LyoStar 3 pilot-scale lyophilizer paired with a complementing Hull production-scale lyophilizer, both equipped with Praxair’s ControLyo™ Nucleation On-Demand Technology.
“By procuring both the pilot-scale and production scale lyophilizers with ControLyo™ technology, AAIPharma significantly enhances its lyophilization development and optimization capabilities while dramatically increasing our scalability and total lyophilization capacity,” stated 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.”
ControLyo™ Nucleation On-Demand Technology allows the manufacturer to control the nucleation temperature during freezing and ensure that all vials nucleate simultaneously. Numerous benefits have been demonstrated for 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 commented as follows: “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 utilize the technology run a real risk of being left behind in a competitive marketplace. We are pleased to see AAIPharma adopt the technology, and believe that as an early adopter they have created a compelling competitive advantage.”
The pilot-scale lyophilizer will be fully validated and operating within AAIPharma’s cGMP facility by February, 2014. The production scale lyophilizer is scheduled to come online in late 2014.