SP Scientific, a leading provider of well-established and highly regarded scientific equipment brands, and AAIPharma Services Corp. (“AAIPharma”), a leading provider of pharmaceutical analytical testing, product development and manufacturing services, 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.
AAIPharma Services Corp. is a leading provider of contract services that support all phases of drug development. The company’s wide array of capabilities includes analytical and formulation development, material testing services, microbiology, clinical and commercial contract manufacturing, pharmaceutical packaging and stability services.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. recently merged to form a premier global supplier of comprehensive CMC services, including process chemistry, solid state chemistry, API manufacturing, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid and sterile), packaging and stability services. The merged company is a portfolio company of American Capital, Ltd .
About SP Scientific
SP Scientific, part of SP Industries, is a leading manufacturer of laboratory-to-production scale freeze dryers / lyophilizers, centrifugal evaporators and concentrators, thermal control systems and glassware washers. More than a scientific equipment supplier, SP Scientific represents brands that distinguish themselves by being able to more thoroughly assist customers in matching equipment to particular application needs. The company sells its products under well-known brands including VirTis, Hull, FTS Systems, Genevac, and National-Hotpack. SP Scientific has ISO 9001:2008 registered production facilities in the USA and Europe.
SOURCE: SP Scientific