ControLyo™ nucleation on-demand technology can now be retrofitted to a wide range of previously installed production freeze dryers. The technology, patented by Praxair Inc., was licensed exclusively by SP Scientific in 2010 for use on development freeze dryers with shelf surface areas < 1.0 sq. m. The technology was incorporated into the Lyostar 3 freeze dryer, the first commercial dryer to offer controlled nucleation capability. Since that time, considerable research has been done at the development scale with controlled nucleation. The technology offers many benefits to freeze drying in the biotech and pharmaceutical industries including improved vial-to-vial uniformity, reduced cycle times, easier process scale-up, reduced protein aggregation and better conformance to the FDA’s PAT, and QbD initiatives. In order for the benefits demonstrated in development work to offer economic benefits to companies, the technology has to be scalable to production freeze dryers. Many commercial production dryers can be relatively quickly and easily retrofitted. It has also been demonstrated on production freeze dryers as large as 300 sq. ft. (27 sq. m), that controlled nucleation was achieved in nearly 9,000 vials, ranging in size from 20 to 100 ml with fill volumes of ¼ and ½. Economical retrofits and scalability of the technology open opportunities to significantly improve production cycles of lyophilized products, with concomitant reduction in cost.
SP Scientific, Stone Ridge, NY 12484. www.spscientific.com or call 845-255-5000
INTERPHEX 2013 Booth No. 2858