Biopharmaceutical filtration is a critical step in the production of biopharmaceuticals, including proteins, antibodies, and vaccines. It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Filtration plays a crucial role in ensuring the safety, efficacy, and quality of biopharmaceutical products. The biopharmaceutical industry uses different filtration systems depending on the type of formulation being purified. These filtration systems use various filter membranes of different sizes. The primary goal behind introducing these filters is to achieve the highest possible purity and yield of the desired biological product, along with maintaining its safety and efficacy for use in human or animal health. However, one of the primary challenges faced by this industry is the high cost and loss of product during the filtration process.
Types of Biopharmaceutical Filtration Systems
The biopharmaceutical industry uses different filtration systems depending on the type of formulation being purified. However, the filtration system used must be biocompatible, non-toxic, and able to withstand the stresses of the filtration process without breaking down or releasing particles into the product.
Depth Filters: Depth filters work by trapping larger particles within the depth of the filter, allowing the fluid to pass through them.
Tangential Flow Filters: Tangential flow filters use a membrane to separate molecules based on their size and concentration.
Virus Filters: Virus filters capture viruses by size exclusion, electrostatic interactions, or adsorption.
Membrane Filters: Membrane filters are typically used for sterilization and removal of smaller impurities such as bacteria and viruses.
Single -use Filters: Single-use filters, also known as disposable filters, are novel filtration devices that are designed to be used once and then discarded.
Others: In bioprocessing, prefilters and chromatography filters use a variety of techniques to selectively remove impurities based on their physical and chemical properties.
How do Biopharmaceutical Filtration Systems Work?
Biopharmaceutical filtration systems works in three simple steps:
Selective Separation: These systems use specialized membranes of precise pore size that allow only selective molecules of certain pore size to pass through it and retain larger contaminants.
Particle Removal: This is the primary function of these filtration systems. It removes bacteria, viruses and other debris using microfiltration, ultrafiltration and nanofiltration.
Concentration and Purification: Biopharmaceutical filtration systems concentrate and purify target molecules by using different filtration techniques. For example, ultrafiltration retains proteins, allowing other molecules to pass through.
What are the Processes Involved in Biopharmaceutical Filtration?
The biopharmaceutical filtration process involves several steps:
Pre-filtration: Before the fluid is passed through the main filtration process, it may be pre-filtered to remove larger particles that could clog the filter membrane.
Main filtration: The fluid is passed through the main filtration system, which typically uses membrane filters that are specifically designed to remove smaller impurities such as bacteria, viruses, and endotoxins.
Post-filtration: After the fluid has passed through the main filtration process, it may be further filtered to remove any remaining impurities or to sterilize the product. are used to remove any residual bacteria, viruses, or endotoxins.
Chromatography filtration: In some cases, chromatography filters may be used to further purify the product. Chromatography filters use a process called adsorption to selectively remove impurities based on their physical and chemical properties.
Techniques Involved in Biopharmaceutical Filtration Process
Biopharmaceutical drugs often require specialized filtration techniques to remove impurities and ensure the final product meets purity and safety requirements. It involves various techniques namely, microfiltration, ultrafiltration and nanofiltration.
Microfiltration: Think microfiltration as a larger sieve. It uses a membrane with a pore size of 0.1-10 µm and separates particles based on their size. This technique is commonly used in biologics manufacturing to remove cells, cell debris, and other large particles from the product.
Ultrafiltration: Ultrafiltration is like a medium-sized sieve. It uses a membrane with a pore size of 1-100 kDa to remove host cell proteins, which are a common impurity in biopharmaceuticals.
Nanofiltration: Imagine nanofiltration as a very fine sieve. It uses a membrane with a pore size of 10-1000 Da to remove small impurities such as viruses and endotoxins.
Advantages of Biopharmaceutical Filtration
Biopharmaceutical filters offer various advantages over other filters as they are available in different diameters and pore sizes. Moreover, they are least absorptive and deliver high throughput rate.
Biopharmaceutical filtration systems are designed to remove impurities and contaminants, to improve safety, purity and shelf life of the product. These filters do not deteriorate sensitive biomolecules such as antibody, vaccines and recombinant proteins.
Challenges Related to Biopharmaceutical Filtration System
Some of the challenges associated with biopharmaceutical filtration systems are mentioned below:
Air Entrapment: Potential air entrapment during filter sterilization by steam.
Loss of product: The filtration process can result in the loss of some of the product, particularly when using smaller pore-sized filters. This can increase production costs.
Clogging of filters: Filters can become clogged over time, reducing their efficiency and requiring replacement. This can add to the cost of production and increase downtime.
Variability: Variations in the quality of the filters used, and the filtration process itself, can lead to product variability, which can affect product quality and consistency.
Applications of Biopharma Filtration
Biopharmaceutical filtration is critical process used in manufacture of biological products such as, antibodies, vaccines, virus removal, blood plasma fractionation, cell culture clarification, cell harvesting, recombinant proteins, DNA and RNA. It uses sterile filtration process in order to protect heat-sensitive biomolecules from damaging. Biopharmaceutical applications are essential in ensuring the safety, quality, and efficacy of the final product. Some common applications are:
Biopharmaceutical applications are essential in ensuring the safety, quality, and efficacy of the final product. Some common applications are:
Sterilization: It is used to remove bacteria, viruses, and other microorganisms from the final product to ensure that it is safe for human use.
Clarification: It can be used to clarify the product by removing impurities such as aggregates, cell debris and host cell proteins.
Concentration: It is also used to concentrate the product by removing excess water and other diluents.
Fractionation: It can be used to separate different components of the product, such as antibodies or proteins, from other components.
Virus removal: It is used to remove viruses that may be present in the product, particularly during the manufacturing of biological products derived from mammalian cells.
The biopharmaceutical filtration domain has garnered significant attention in the last decade. This popularity can be attributed to rising demand for biologics and various technological advancements in the biopharmaceutical filtration industry. Further, the demand for advanced and user-friendly filtration systems has been augmented due to the increase in research and development expenditure in the biopharma domain. Over the years, biopharmaceutical filtration has evolved to incorporate novel types of filtration systems that offer several advantages over conventional filtration systems. These novel categories include single-use filters, chromatography filters, tangential flow filters, tangential flow depth filters and virus filters. These systems can be applied to a wide variety of application areas due to their flexible nature. As the industry continues to evolve, there will likely be a continued focus on improving efficiency, reducing costs, and ensuring regulatory compliance.