BioProcess International Poster Preview: Evaluating the Impact of Controlled Nucleation on Lyophilized Product Attributes and Processing Characteristics in an Aseptic Environment

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place September 16-19, 2013 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Evaluating the Impact of Controlled Nucleation on Lyophilized Product Attributes and

Processing Characteristics in an Aseptic Environment

Presenter: Wendy Sunderland, Lyophilization Technology, Inc

About the Poster: ControLyo™ Nucleation on Demand technology (ControLyo) is an innovative technology that improves the uniformity of nucleation of ice in product vials during freezing within the lyophilizer. Processing of model crystalline and amorphous systems was performed in a 48-square foot lyophilizer in an aseptic environment. Lyophilization cycles were performed for both model systems using either ControLyo or a standard freezing method, resulting in product vials nucleating simultaneously and randomly, respectively. The product vials from both studies were then dried using identical primary and secondary drying temperatures, pressures, and times. There is significant work in the literature of laboratory studies evaluating controlled nucleation of ice on resulting product characteristics; however, there is limited, if any, research including product processed in an aseptic Good Manufacturing Practices (GMP) facility. The studies encompassed product temperature data and finished product characteristics of two model systems processed in an aseptic facility. In particular, effects of controlled nucleation and freezing, sublimation, and desorption will be compared. These will be reflected through product temperature data and physical appearance, reconstitution behavior, pH, and residual moisture content. Early indications are there are subtle differences in some lyophilized product attributes between samples utilizing ControLyo and samples utilizing a standard freezing method. The data presented will offer insight into the effect on freezing and drying behavior, as well as finish product characteristics of controlled ice nucleation technology compared to the standard freezing method.

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