Membrane Solutions CleSep Hollow Fiber Filters

With the rapid development and maturity of the biopharmaceutical industry, the scale of the biopharmaceutical upstream filtration market will continue to expand. As an important product of tangential flow filtration technology, hollow fiber membrane plays an irreplaceable role in biopharmaceutical filtration process due to its unique open flow channel design and simple and controllable fluid shear force. In this article, Xiaomai will introduce our company's new product -- hollow fiber filters.

Hollow Fiber Membrane Separation Technology

Hollow fiber adopts tangential flow filtration to form a fibrous membrane tube structure from a membrane with a certain pore size (such as 0.45μm). The cell culture medium flows through the membrane tube to form a tangential flow, and the target antibody passes through the membrane pore, while the cells and cell fragments are intercepted, and the clear culture medium is obtained by collecting through the end.

Tangential flow filtration membrane can be divided into ultrafiltration membrane and microfiltration membrane according to the pore size: ultrafiltration membrane with smaller pore size is commonly used for protein concentration; Microfiltration membrane with larger pore size (such as 0.45μm) is commonly used for the removal of cells and cell fragments in culture media, to achieve the clarification of the liquid before chromatography.

Schematic Diagram of Tangential Flow Filtration (Image Source: The Biotechnology Industry, 2009)

Open Channel Structure of Hollow Fiber Filter (Image Source: The Biotechnology Industry, 2009)

Membrane Solutions CleSep Hollow Fiber Filters

Membrane Solutions has been developing domestically produced pharmaceutical grade hollow fiber membranes since 2018. After years of research and exploration by the R&D team, as well as strong market driving forces, it has gradually improved product performance. Currently, it has completed the development of various specifications of hollow fiber membrane products.

1、Product Features

Membrane Solutions provides 12 options of different dimensions for hollow fiber filters, which can be applied in R&D phases, pilot and commercial production. The hollow fiber filters adopt automatic production process, which ensures the consistency of its performance and the simple and reliable scalability from laboratory to production. The material of the hollow fiber filters provides excellent chemical compatibility and can tolerate a variety of chemical cleaning agents to ensure safe and effective cleaning and disinfection of the filtration system.

• Scalability from laboratory to production

Hollow Fiber Filters of Different Specifications (Small-scale, Pilot, and Commercial)

• Modified polyethersulfone material, good chemical compatibility, lower protein binding, lower blockage, higher pollution resistance and yield

Flow Rate Attenuation Curve of 1g/L BSA Solution (The initial BSA concentration is 1.0g/L, and the BSA concentration after testing is 0.97g/L)

• Highly asymmetric structure, narrow membrane pore size distribution, higher flow rate, and better retention effect

• Complete and reliable filter design, without the need for additional assembly and fixtures, easy to install and clean

• Good chemical compatibility, able to withstand higher temperatures and pressures, as well as higher cleaning concentrations (1N NaOH)

2、Applications

Principles for selecting membrane pore size:

• Transmission mode: The membrane pore size should be at least 5-10 times larger than the target molecule.
• Retention mode: The pore size of the membrane is 1/3-1/5 of the target molecular weight.
• Separation (purification) of two substances: a 10-fold difference in molecular weight.

• Membrane Material

Compared to traditional polyethersulfone, CleSep hollow fiber membrane uses modified polyethersulfone material. The membrane prepared from it not only has a higher flow rate and filtration load, ensuring shorter process time and higher yield, but also has characteristics such as low protein binding, low blockage, and easy cleaning. The modification technology has optimized the rigidity characteristics of polyethersulfone, improving the flexibility of the membrane material and being able to withstand higher process disturbances and shear rates.

SEM Image of 0.22um PES Hollow Fiber Membrane

1. Product Specifications

MS hollow fiber filters offer 10 different sizes and specifications, which can be used for R&D phases, pilot and commercial production. The filter has consistent performance and simple and reliable linear amplification performance with different area. The filter material composition has excellent chemical compatibility and can be compatible with various chemical cleaning agents, ensuring safe and effective cleaning and disinfection of the filtration system.

The effectiveness of hollow fiber filters is closely related to the characteristics of the feed liquid, filtration accuracy, and tangential flow parameters, and needs to be tested and optimized based on the material condition. For specific information, please consult Membrane Solutions application technology experts.

The typical usage diagram is shown below:

Hollow Fiber Filter VS Flat Sheet Cassette

Hollow fiber and flat sheet cassette belong to tangential flow filtration technology, but each has its own characteristics in application. For example, hollow fiber filters are commonly used for cell culture perfusion, cell clarification, bacterial collection, and clarification of bacterial debris, virus particle collection and purification, insulin crystal collection, and treatment of liposomes and other shear sensitive samples. Opening the flow channel is also beneficial for reducing the resistance of the sample to move forward, making it suitable for samples with high solid content and viscosity. If the sample is not sensitive to shear force, the mesh of the flat sheet cassette helps to improve mass transfer efficiency, thereby increasing filtration flux and speed, including sample concentration. So the application of flat sheet cassette is very common in downstream processes of antibodies, recombinant proteins, vaccines, and blood products. In addition, there are differences between the two in terms of usage and environment. Hollow fiber filters can provide high-pressure sterilization, SIP, and presterilization products to meet the requirements of sterile processes.

In the field of biopharmaceuticals, tangential flow filtration of hollow fiber filters can be applied in cell perfusion culture, clarification filtration, concentration and liquid exchange, and other processes. In the domestic market, this product is basically monopolized by imported brands, with high prices, long supply cycles, and limited audits, which restrict the rapid development of the domestic biopharmaceutical industry. Membrane Solutions has been focusing on the research and production of filtration, separation, and purification products for 16 years. It is the first tier of industrial process filtration product localization, and creates filtration products according to imported brand standards. It is your high-quality choice for domestic substitution. If you are interested in our products, please contact us for more information and samples.

The ordering information is as follows:

References:

【1】 Miao Jingyun, Sun Wengai, Jie Hongyan. The application of hollow fiber membrane filtration technology in the production of monoclonal antibodies [J] Biotech, 2009 (2): 57-64

【2】 The Age of Medicine

https://www.drugtimes.cn/2022/08/05/wanzichangwenconglilundaoshengchanyiwendudongmrnalnpzhijijis/