Hull production-scale lyophiliser.
SP Scientific, a leading provider of well-established and highly regarded scientific equipment brands, and AAIPharma Services Corp., a leading provider of pharmaceutical analytical testing, product development and manufacturing services, have entered into a purchase agreement where 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 lyophilisation 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: “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. 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 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.
SP Scientific Inc., +1 845 255 5000, shireen.scott@spscientific.com, www.spscientific.com.