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Introduction to Vial Fogging and Mitigation Strategies

Kevin BondAbout Our Speaker: Dr. Bond is a research associate at Baxter Healthcare located in Bloomington, Indiana. He is responsible for contract formulation and process development of sterile products with a specialty in freeze-drying. Dr. Bond has spent his first few years at Baxter studying vial fogging and ways to mitigate the impact of fogging on biologic drug products. His interests include formulation and lyophilization cycle development for biologics. Before Baxter Dr. Bond earned his Ph.D. in Analytical Chemistry from Indiana University under Dr. Martin Jarrold where he studied the physical properties of virus capsids on home built mass spectrometry instrumentation.

 

Abstract: 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. While a haze is one common presentation of fogging the appearance can vary widely and can appear as a dendritic pattern, branching, or a uniform haze covering the interior of vials. Vial fogging is often considered a cosmetic defect as the acceptable appearance of fogging can vary based on specific markets. However, some products can exhibit severe vial fogging where the dried product is observed in the neck region of the vial. Dried product in the neck region of a vial can compromise container closure integrity resulting in a risk of sterility failure. This can lead to the rejection of batches of product which are often costly to produce. Therefore the understanding, prevention, and reduction of vial fogging becomes significant when considering the loss of product.

 

Webinar Highlights:

  • This webinar introduces vial fogging in the context of lyophilized drug products
  • Overview of risk factors which may lead to vial fogging
  • Current strategies to eliminate or reduce vial fogging

Download transcript of Webinar

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