Presented by Dr. J. Jeff Schwegman, PhD, CEO of Labyrinth Biopharma…
Webinar Category: Freeze-Drying
Lyophilization Basics: An Introduction to Freeze-Drying (Part 2 of 4)
Presented by Dr. J. Jeff Schwegman, PhD, CEO of Labyrinth Biopharma…
Lyophilization Basics: An Introduction to Freeze-Drying (Part 1 of 4)
Lyophilization Basics: An Introduction to Freeze-Drying (Part 1 of 4) covers: Presented by Dr. J. Jeff Schwegman, PhD, CEO of Labyrinth Biopharma…
The Application of QbD to Freeze-Drying
The application of a Quality by Design (QbD) approach to the development of a freeze-dried pharmaceutical product is a complex science and still a matter of much debate. It certainly requires knowl
Vacuum Integrity Testing of Freeze Dryers
This webinar will summarize and clarify terms and issues concerning the vacuum integrity testing of freeze dryers. Because the lyophilization process occurs in an evacuated vessel, users of fre
Solving Scale-Up Problems in Freeze-Drying of Pharmaceuticals
It is well known that freeze drying processes developed in the laboratory that perform well in the laboratory often encounter problems in manufacturing. Perhaps the most common problem is collapse
Controlled Ice Nucleation Process Development Product Quality
The freezing stage is the only portion of the freeze-drying process that normally remains largely uncontrolled. Ice nucleation is a stochastic process, so the degree of super-cooling varies both in
Lyophilized Drug Product Development: An Industry Perspective
Biopharmaceuticals are routinely freeze-dried to improved product stability and, thereby, achieve acceptable commercial shelf life. However, freeze-drying is a unit operation coupled in formulation
The Influence of Mannitol Hemihydrate on the Secondary Drying Dynamics of a Protein Formulation: A Case Study
The objective of the research was to study the atypical secondary drying dynamics observed during the freeze-drying of a protein formulation containing mannitol, trehalose, and sodium chloride, whe
Lyophilizer Sublimation and Heat Transfer Modelling – Basic Principles and an Industrial Case Study
Operational Qualification of Freeze Dryers is traditionally performed using empty chambers. Secondly, scaling up or transferring Freeze Drying cycles is often empirical, and not necessarily science