Webinars

Presentation by T.N. Thompson, Founder and President of Millrock Technology

An emerging approach to lyophilization process development is to construct a graphical design space for primary drying as an aid to process optimization.

Lyophilized beads are spheres made of lyophilized material containing a certain concentration of selected components. They are a very versatile system that provides long term stability, quick reconstitution, and easy handling.

In lyophilized drug and biological products, crystallization of ice and excipients impart stresses on the walls of the vial which can be detected with a strain gauge. During the freezing process of lyophilization, there can be significant sample loss from vial breakage leading to loss of process control and additional cleaning expenses.

The rigidity (stiffness) of the substrate to which cells adhere can have a profound effect on cell propagation, differentiation, lineage specification, gene expression, morphology, self-renewal, pluripotency and migration.

The MicroFD by Millrock Technology offers unique features for freeze drying practitioners. Few vials are processed, thus minimizing the cost of process development and shortening the stages of batch preparation & loading, condenser defrosting, etc.

Vial fogging is a phenomenon commonly observed in lyophilized biologic drug products and has been widely reported in the pharmaceutical industry. The appearance of vial fogging presents as a haze of dried powder which is visible above where the dried cake meets the inner surface of the vials.

In the freeze drying world, most of the work and literature published is related to vial freeze drying and does not touch on some of the differences that are only seen when working with bulk materials. This webinar will highlight some of the most common challenges users face when freeze drying bulk material as well as some of the features that users should be attentive to when selecting a freeze dryer to be used in a bulk application.