Advancing Process Filtration in Bioprocessing
Filtration solutions are essential throughout upstream and downstream bioprocessing workflows to remove product impurities, reduce bioburden, ensure sterility, exchange buffers, and concentrate active pharmaceutical ingredients to the desired level. Sartorius offers filtration solutions that support a wide range of applications and unit operations, from small-scale development to commercial production, maximizing productivity while optimizing quality, cost, and capacity. With decades of experience and deep expertise, Sartorius is a trusted partner, delivering innovative process filtration solutions tailored to the demands of modern bioprocessing.
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Sartorius ensures seamless integration of comprehensive filtration solutions across multiple unit operations in bioprocesses.
Sartorius pairs its extensive experience with professional expertise, aligning development initiatives with the latest industry trends for exceptional filtration performance, as demonstrated by our proactive approach to the PFAS ban and the development of our newest Sartopore Evo® PES Membrane Filters.
Our global manufacturing network and distribution centers ensure reliable delivery through several production sites and a versatile supplier network.
Sartorius delivers efficient standard filtration solutions and adapts to complex, customized needs, ensuring tailored support for every requirement including hybrid stainless steel | single-use solutions as well as single-use and multi-use systems.
Supported by rigorous validation and extractable data along with a comprehensive quality management system, our filtration solutions meet regulatory standards in pharma and biotech applications.
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Frequently Asked Questions
Process filtration in bioprocessing refers to the use of various filtration techniques to separate and purify components within a biopharmaceutical production process. Process filtration is applied at different stages to optimize efficiency, meet regulatory standards, and enhance the efficacy of pharmaceutical products.
Filtration in downstream processing is a critical step used to separate and remove unwanted particles, such as cell debris, viruses, and bacteria, from the product stream. This process ensures the purity and quality of the final product by filtering out impurities and concentrating the desired components such as the active pharmaceutical ingredients (API).
Filtration is essential in bioprocessing, used at key stages to ensure product purity and quality. Initially, it removes cell debris and large particles from cell cultures. During intermediate steps, it concentrates and purifies biomolecules like proteins and nucleic acids. In final purification, filtration ensures sterility by eliminating viruses, bacteria, and contaminants, meeting regulatory standards. It also maintains product integrity during storage or packaging, preventing contamination. It`s furthermore used to prefilter buffer solutions and additives used in the purification of the API.
There are several types of filtration and separation processes, each designed to address specific needs in various applications:
- Sterile Filtration: Removes microorganisms to ensure sterility in pharmaceutical products.
- Depth Filtration: Captures particles within the filter matrix, ideal for removing larger contaminants.
- Virus Filtration: Utilizes filtration membranes with nanopore structure to also target and remove viruses from the product stream.
- Viral Inactivation: Reduces viral activity of enveloped viruses through physico-chemical treatments complementing virus filtration and other virus clearance steps.
- Centrifugation: Separates components based on density differences using rotational force.
- Prefiltration: Prepares the product stream by removing larger particles and aggregates before actual filtration steps.
Each filtration and separation type is selected based on the specific requirements of the process, ensuring optimal performance and product quality.