By Dr, Andrew Bright Ph.D., Biopharma Group, UK
Freeze-drying (lyophilization) is a means of stabilizing a perishable product and extending its shelf life and is frequently used in the pharmaceutical industry for drugs, vaccines, antibodies and other biological material. The freeze-drying process has several steps, each requiring careful optimization to maintain a product’s quality and function after drying. With each product, optimization conditions may differ, and these may also change when scaling up to product manufacturing. Several assumptions based on previous knowledge or experience are often made but as with many techniques that have become well-developed over time, there remains a number of misconceptions that persist in this process.
Recently, Dr. Andrew Bright, Ph.D., Senior Scientist at Biopharma Group, UK presented a two-part series of webinars questioning ten assumptions that are made when developing the freeze-drying process for pharmaceutical products and how these may be counteracted. This tech note summarizes both webinars and includes a selection of questions from the Q&A sessions.