Membrane filtration technology is a physical separation method that can separate molecules of different sizes and properties. It has been widely used in downstream bio-purification processes to reduce production costs and increase batch processing volume. CD Formulation integrates cutting-edge membrane filtration technology into our protein characterization technology platform to provide reliable support for the downstream process development of your protein/peptide drugs.
Membrane filtration, a high-throughput technology that separates substances according to size specifications, can be used for microfiltration clarification and sterilization, as well as ultrafiltration protein concentration and liquid exchange. Its driving force is the pressure difference on both sides of a special membrane. Membrane filtration can be dead-end filtration or cross-flow filtration.
Compared with dead-end filtration, cross-flow filtration has significant inherent advantages. Because the treated liquid flows continuously through the membrane, there is no filter cake that can cause scaling and uneven flow. In addition, dead-end filtration does not require filter aids and the membrane has a longer service life, which makes continuous and automated filtration processes possible, thereby achieving consistent and controllable product quality.
Fig.1 Comparison between: (a) dead-end, (b) cross-flow configuration. (Saxena A, et al., 2009)
Thanks to decades of experience supporting protein/peptide biopharmaceutical development and manufacturing using membrane filtration technology, our team of highly qualified experts offers a range of membrane filtration-related services to accelerate the implementation and success of your project.
Our experienced team of experts has completed hundreds of membrane filtration separation and purification projects for protein and peptide, supporting all stages of your protein/peptide drug development and manufacturing - from early studies to downstream process monitoring and GMP batch release testing.
Utilizing cutting-edge membrane filtration technology, we support the following protein/peptide development and characterization plans, including but not limited to:
In our downstream purification process development for protein pharmaceuticals, four commonly used membrane filtration technologies include reverse osmosis (RO), microfiltration (MF), ultrafiltration (UF), and nanofiltration (NF). These technologies are selected based on the size of the species they need to separate from the feed liquid.
Fig.2 Membrane filtration types. (CD Formulation)
MF involves capturing particles larger than ~0.1 µm with porous membranes, allowing the separation of larger particles, cell debris, and microorganisms from protein solutions.
UF is used to concentrate proteins and remove low molecular weight impurities. It is typically operated using membranes with pore sizes typically in the 1-100 kDa range, allowing water and small solutes to pass through while retaining larger proteins.
NF is used to selectively separate molecules based on size and charge. Small molecules can be concentrated while larger organic compounds are retained. Pore sizes are typically in the 1-10 kDa range.
RO is designed to deionize solutions and achieve higher purity in protein applications by removing salts and other small molecules. It is typically operated at high pressure, forcing the solvent through a semipermeable membrane. In principle, water is the only substance that can permeate the membrane. All other substances, such as bacteria, proteins, colloids, salts, sugars, minerals, etc., can't pass.
Published Data
Technology: Ultrafiltration (UF)
Journal: Separation and Purification Technology.
IF: 8.1
Published: 2016
Results:
The authors investigated the ability of ultrafiltration (UF) membranes to remove proteins (bovine serum albumin (BSA) or lysozyme (LYS)) from silica nanoparticles in dispersed mixtures. RC and PES UF membranes with different nominal molecular weight cutoffs (NMWCO) were used. The molecular weight cutoff was experimentally determined to be 180 kDa. Membrane characteristics and filtration conditions, particularly pH and flux, were selected or adjusted based on single-component feed data to achieve maximum protein transport with complete silica retention. Batch dead-end and continuous diafiltration processes were used for fractionation and purification. Results showed that both RC and PES UF membranes could achieve quantitative retention of silica and the retained silica nanoparticles remained stable in the dispersion without any signs of aggregation.
Fig. 3 Schematic concept for the purification of metal oxide nanoparticle dispersion by removal of proteins through the membrane. (Alele N, et al., 2016)
CD Formulation aims to provide a powerful analytical tool for the separation, purification, and characterization of proteins and peptides. Please feel free to contact us if you are interested in our services. Learn how our membrane filtration technology can support the smooth implementation of your protein/peptide biopharmaceutical program.
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