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Microfiltration in biotechnology: characterisation and scale up
Published on February 27, 2020 28 min
A selection of talks on Pharmaceutical Sciences
RNA therapeutics: clinical applications and methods of delivery
- Prof. John P. Cooke
- Houston Methodist Research Institute, USA
Overview of nonclinical safety assessment
- Dr. Claudette L. Fuller
- Merck Research Laboratories, USA
Drug-induced liver injury: risk factors and drug development in DILI
- Prof. James H. Lewis
- Georgetown University Medical Center, USA
Drugging conformational states of GPCRs
- Prof. Dr. Peter Kolb
- Philipps-Universität Marburg, Germany
I am Pouria Motevalian and I am scientist in Bioprocess Research and Development in Pfizer. Today, we will talk about characterization and scale up of microfiltration processes for biotechnology application.
Here is the outline for today's talk. First, we review the background on application of membrane filtration for manufacturing biotechnology products, then we focus on microfiltration and review microfiltration devices and membrane chemistries. Next, our focus shifts toward a sterile filtration as one of the most commonly used form of microfiltration and review sterile filtration membrane fouling. Then we talk about the scale up of a sterile filtration processes and membrane sizing for a sterile filtration application and finish with a summary.
Membranes are extensively used in production, purification, and formulation of biotechnology products. From size and application perspective, membrane filtration can be categorized into four categories: microfiltration, ultrafiltration, virus filtration, and nanofiltration. Microfiltration membranes typically retain bacteria, cell debris, and intact cells by passing colloids, viruses, proteins, and salts. The approximate pore size for microfiltration membranes spans from 50 nanometer to 10 micron which makes them suitable for multiple upstream and downstream applications. Upstream applications of microfiltration include a sterile filtration of fermentation media, pH control solutions, and gases. Tangential flow microfiltration is used for medium exchange, perfusion, and harvest. Downstream applications of microfiltration include a sterile filtration of buffer products and gases, which are typically air and nitrogen. In upstream, virus filtration may be used to protect cell culture from introduction of viral contaminants in media raw material. Virus filters are often used in the downstream processing of cell culture dry product to ensure removal of both viruses that may enter into the cell through contaminated raw material or virus particles. The approximate pore size for virus filters is 20 nanometer to 70 nanometer and these filters are designed to retain viruses while allowing protein and buffer components to pass through. Ultrafiltration membranes typically retain proteins while allowing amino acids, anti-foam, and buffer components to pass through. The approximate pore size for ultrafiltration membranes is one nanometer to 20 nanometer and these membranes are widely used in downstream to concentrate and buffer exchange the product pool. It is also used for final formulation of bulk products. Finally, nanofiltration is used for retaining multi-valent salt, sugar, amino acids, and antibiotics. Nanofilters have pore size in the range of 0.1-1 nanometer.