On-Demand Webinars

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.

The emergence of cell and gene therapies and new COVID-19 vaccines brings the promise of treating some of the most challenging diseases. Storage, transport, and delivery of these breakthrough therapies for safe clinical use has its own set of challenges.

Antibody drug conjugates (ADCs) are antibodies equipped with a small number of chemotherapeutic molecules with the aid of a linker system.  They have grown in importance because the antibody targets specific cells where they drop off their payload of chemotherapeutic molecules.  This is a huge advantage to chemotherapy. 

Due to the product pre-conditioning in individual vials, freeze-drying process can be difficult to design and often results in batches presenting a significant heterogeneity in the quality of the final product. This webinar focuses on the understanding and quantification of the sources responsible for heat and mass transfer variability during the process.

The purpose of this webinar is to describe the types of in-process data that can be collected and provide examples of their use. In-process data collected at full-scale are valuable for demonstrating the success of scale-up, for routine process monitoring, and for solving problems that may occur during the process.