The development of biopharmaceuticals often requires lyophilized formulations to produce stable drug products, beginning with laboratory experiments followed by scale-up to larger lyophilizers. Limited supply and high cost of Active Pharmaceutical Ingredient (API) can present major challenges during formulation and process development. It’s necessary to have enough API to properly screen formulations for freeze drying feasibility, to understand critical product attributes, and to define product and process design space in order to create a robust freeze-drying process.
An accurate representation of drying conditions cannot be concluded by just placing a few vials of API within a larger freeze dryer due to atypical radiation conditions that can result from vials which are not situated in a close-packed formation, or are not able to fill the freeze dryer’s shelf surface. Atypical radiation effects can lead to variations in product temperatures and drying times, resulting in non-representative cycles.
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This study’s focus was to assess the capability of SP Scientific’s new LyoCapsule™ Freeze Dryer to emulate the product temperature history of a larger laboratory dryer often used for process development. This was achieved by comparing the radiation environment of the LyoStar 3 process development freeze dryer to the LyoCapsule™ Freeze Dryer.
The LyoCapsule freeze dryer's small chamber incorporates a unique cylindrical inner chamber, or ‘capsule,’ to hold the vials and utilizes wall temperature control to ensure that edge vials dry under the same process conditions as center vials. Employing this technology, this mini freeze dryer was designed to mimic the performance of a larger development freeze dryer.
The results of the study confirmed that product temperature histories and drying times can be conserved between the LyoCapsule™ Freeze Dryer and LyoStar 3 Process Development Freeze Dryer by controlling the wall temperature. The authors conclude that the LyoCapsule™ Freeze Dryer offers a highly effective resource for formulation and process development of lyophilized pharmaceuticals. The study also established that the LyoCapsule™ Freeze Dryer can be used for a variety of research applications. This includes to ensure that critical formulation collapse temperature is not exceeded during primary drying; to define proper shelf temperature and pressure selection for effective sublimation processes; and to plan process scale-up and perform “scale-down” experiments to troubleshoot issues encountered in commercial freeze dryers while utilizing minimal API.
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