Webinar: Production and Sterilization of Biopharmaceutical Nanoemulsions using Filtration

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Wednesday, February 28, 2018Description :
00:00 Introduction (Kyle Jandrasitz, Microfluidics) 03:15 Squalane emulsion production (Kyle Jandrasitz, Microfluidics) 08:18 Introduction to pharmaceutical filtration (Ross Turmell, Pall) 20:40 Sterile filtration of a squalane emulsion (Dr Martha Folmsbee, Pall) Nanoemulsions have many advantages to the pharmaceutical industry as drug delivery systems. These advantages include increased drug loading, enhanced bioavailability, protection from degradation, and controlled drug release. Additionally, the ability of nanoemulsions to enhance immune response makes them useful as vaccine adjuvants. Large scale production of pharmaceutical nanoemulsions requires precise control of particle size and size distribution since both will determine the stability of the nanoemulsions, and greatly affect terminal sterile filtration. Due to the nature of many of these drug delivery systems (or the drug itself) terminal sterilization with heat is often not an option, and sterile filtration is employed. However, validation of sterile filtration with these solutions can require increasingly robust technical solutions. This educational webinar presents an example of the process development of a drug delivery nanoemulsion using Microfluidics' innovative high pressure, high shear fluid processing technology in combination with successful sterile filtration utilizing a pre-filtration step (Supor® Grade EKV 0.2 µm rated filter) followed by sterile filtration at three different pressures (15, 30 and 60 psid) with a Fluorodyne® EX Grade EDF filter. The unique capability of a Microfluidizer to produce nanoemulsions with targeted size and size distribution are demonstrated. Viewers will learn: - The unique advantages of Microfluidizer® and interaction chamber technology - Process development for producing pharmaceutical nanoemulsions

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