Pharmarceutical & Biology

Biological products refer to drugs prepared for the prevention, treatment and diagnosis of human diseases, and they are prepared from biological materials such as microorganisms, cells, tissues and liquid of various animals and human origin, which are obtained through genetic engineering, cell engineering, protein engineering, fermentation engineering and other biotechnology. Because biological products need go through multiple biological processes, purification processes for impurities removal, etc. to obtain the target products, biological products have extremely complex uncertainties in each link, and there are strict requirements for the quality control of biological products throughout the process, so filtration is very important to its process control.

Take vaccines as an example
Vaccines refer to vaccine-based preventive biological products used for human vaccination in order to prevent and control the occurrence and prevalence of infectious diseases and refer to an automatic immune preparation for the prevention of infectious diseases that is made by pathogenic microorganisms (such as bacteria, rickettsia, viruses, etc.) and their metabolites through artificial attenuation, inactivated or transgenic methods. At present, most of the vaccines in use are used to prevent viral or bacterial infections, and they are mainly divided into inactivated vaccines, live attenuated vaccines, endotoxins, subunit vaccines, polysaccharide vaccines, nucleic acid vaccines (DNA vaccines and RNA vaccines) and so on.
In sterile pharmaceuticals, filtration technology plays a pivotal role in the quality of drugs as a means of reducing or removing microorganisms (bacteria, mycoplasmas, bacteriophages, endotoxins, etc.). It has a wide range of applications in different process stages of vaccine filtration, mainly including sterilization filtration of culture medium, sterilization filtration of gas, sterilization filtration of buffer fluid, clarification filtration of dead cells and cell debris, ultra-filtration concentration, chromatography purification, sterilization filtration of terminal products, etc.

The main filtration sites are:

1. Filtration of medium: remove bacteria and microorganisms from cell culture medium
2. Gas filtration: remove microorganisms such as bacteria from gas
3. Filtration of buffer fluid: sterilization filtration of buffer fluid, extend the service life of chromatography column and ultra-filtration membrane
4. Clarification filtration: removal of dead cells and cell debris as well as impurities such as lipids, colloids, particles
5. Security filtration: prefiltration before ultra-filtration to protect the ultra-filtration module
6. Terminal sterilization filtration: remove bacteria and microorganisms from terminal filtrate

The process of traditional vaccine production and filtration is roughly as follows:

After understanding the process needs of customers, Membrane Solutions provides customers with stable and reliable products for a long time, and can provide perfect filter cartridge process validation. Membrane Solutions has a complete process Validation Service Center with complete management procedures, standard test procedures and standard operating specification, which is divided into core validation service center/process validation service center. It provides a variety of testing and validation services for pharmaceutical companies and filter manufacturers. Its validation support services simplify the validation process for customers in terms of filter regulations, making the entire vaccine preparation process more cost-effective and reliable. Its recommendations for the filtration and applications of the main sites in the production process of vaccine are as follows:

For detailed technical solutions, please contact your MS sales engineer.