Lyo Controlled Ice Nucleation

Lyo Controlled Ice Nucleation

Assessing Process Performance of
Controlled Ice Nucleation

Analyzing the controlled ice nucleation process with a focus on the process performance and product attributes

What is controlled ice nucleation?

Lyophilization, or freeze-drying, has been around for centuries, dating back as far as the 13th century. However, in the past few decades there has been little change to process design, monitoring, and quality control assessment. Controlled ice nucleation (CIN) technology is a new method to improve efficiency in time and cost for lyophilization in addition to increasing batch homogeneity and product quality. The technique involves cooling the batch to a specific temperature in order to reduce the randomness that ice generation can bring to a lyophilized sample such as ice crystal size and distribution. DigiM’s non-invasive X-ray imaging has been used to improve the understanding of the relationships between CIN process parameters and performance with product quality attributes. With AI technology, microstructure quality attributes including microporosity and cake wall thickness can be directly quantified. 

controlled ice nucleation CIN freeze drying lyophilization microporosity

Quantitative data gathered from XRM images using artificial intelligence to calculate the microporosity size of two samples processed at different temperatures. 


Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using 3D XRM Analytics

Drug Development and Delivery Paper in collaboration with BMS and Moderna

Non-invasive 3D X-Ray microscopy imaging technique for quantitative characterization of lyophilized drug product

IFPAC 2021 Presentation in collaboration with Dr. Maxwell Korang-Yeboah from the FDA

Assessing the risk of changes in container closure system of a freeze-dried product on primary drying efficiency and product quality

IFPAC 2021 Presentation by Dr. Maxwell Korang-Yeboah from the FDA featuring DigiM analysis