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Production & Sterilization of Biopharmaceutical Nanoemulsions using Filtration: Microfluidics and Pall Life Sciences Collaborate to Develop a Filtration- based Alternative to Terminal Sterilization for a Squalane Emulsion

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 will present an example of the process development of a drug delivery nanoemulsion using MicrofluidicsTM 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.

Participants will learn:

  • The unique advantages of Microfluidizer® and interaction chamber technology.
  • Process development for producing pharmaceutical nanoemulsions.



Moderator and Presenter

Kyle Jandrasitz

Application Research Engineer
Microfluidics International Corporation

Kyle Jandrasitz has been an Applications Research Engineer at Microfluidics International Corporation for the past two years. Kyle has earned a Bachelor’s in Industrial Technology, Nanofabrication Manufacturing Technology from Millersville University of Pennsylvania and a Master’s in Engineering Management from Pennsylvania State University. Prior to joining Microfluidics International Corporation, Kyle spent two years at Structure Probe, Incorporated as a Microscopist.



Presenter

Ross Turmell

Senior Technical Specialist
Scientific and Laboratory Services
Pall Life Sciences
(Southern California, USA)

Ross Turmell is a Senior Technical Specialist in the Global BioPharmaceutical Aseptic group in the Pall Scientific and Laboratory Services division. Ross specializes in aseptic bulk drug processing design and the incorporation and use of all types of filtration. His work includes selecting, sizing and testing filtration products in both laboratory and bulk drug processing settings. Ross has held technical leadership and bulk drug processing positions at Pall Corporation, Amgen Inc. and Baxter BioScience Inc. and has over 15 years of bulk drug processing experience in both Upstream and Downstream operations. Ross hosts regular technical seminars and training forums with a focus on biopharmaceutical processing for Pall Corporation in the Southern California area. Ross received a Bachelor of Arts in Biology from California State University at Northridge in 1999.




Presenter

Martha Folmsbee, Ph.D.

Principal Scientist
Scientific and Laboratory Services
Pall Life Sciences
(Port Washington, NY, USA)

Martha Folmsbee is a Principal Scientist in the Scientific and Laboratory Services department at Pall Corporation, based in Port Washington, NY. Martha specializes in bacterial and bacteriophage retention testing of sterilizing grade filters. Her work includes a special focus on mycoplasma filtration (mycoplasma clearance) and sterile filtration of low surface tension fluids, particularly in relation to specific customer applications. Martha received a Masters in Environmental Science from the University of Oklahoma in 1997 and later her PhD in Microbiology in 2004. For her PhD dissertation, she studied the physiology and nutritional requirements of anaerobic growth and biosurfactant production of Bacillus mojavensis and several other bacilli. In 2005, she was awarded an ASM/NCID (American Society for Microbiology/National Centers for Infectious Disease) Post Doctoral Fellowship to work at the CDC (Center for Vector Borne Disease) in Fort Collins, CO. There, she studied the physiology and nutritional requirements of Borrelia burgdorferi with a focus toward the development of defined media for the culture of this organism.






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  • Active pharmaceutical ingredients
  • Animal health
  • Bioprocess engineering
  • Biotechnology
  • Drug discovery
  • Formulation and filling
  • Molecular diagnostics
  • Pharmaceutical QC
  • Plasma fractionation
  • Vaccines
  • Other
  • Cell culture
  • Chromatography
  • Clarification and prefiltration
  • Concentration & diafiltration
  • Process monitoring
  • Protein Structure and Function
  • Purification
  • Separation/filtration
  • Sterile filtration and bioburden control
  • Venting and gas filtration
  • Viral clearance
  • Other
  • Upstream (cell culture/fermentation/harvesting)
  • Downstream (purification/formulation & filling)
  • Both
  • Neither
  • Bioreactors
  • Filter Capsules
  • Chromatography products
  • Connectors
  • Housings
  • Integrity test instrumentation
  • Sheet filters and sheet filter modules
  • Single-use systems
  • Systems (biopharmaceutical)
  • Tangential flow/crossflow products
  • Testing and monitoring products
  • Filling Needles
  • Connector validation
  • Consulting services
  • Contamination analysis
  • Filter validation
  • Pre-inspection reviews
  • Process development
  • Process proteomics
  • Single-use validation
  • Test equipment validation
  • Contract analytical services