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Integrated Single-use Solutions for the Manufacture of Biopharmaceuticals
Safety, flexibility and efficiency are playing an ever-increasing role in the manufacture of biopharmaceuticals. For this reason, demand is steadily rising for sterile single-use products and systems that connect these products easily, flexibly and safely. Configurable and scalable system solutions, such as FlexAct®, can be used in all process steps – in preparation of media and buffers, cell harvesting, crossflow filtration, viral clearance, virus inactivation, polishing and in the form - fill and form - transfer process steps.
Cell Cultivation in Biopharmaceutical Processes
To enable cells to grow optimally in the production of active pharmaceutical ingredients, cells are cultivated in a bioreactor under controlled conditions. Important factors for cell growth include the composition of the nutrient medium, mixing efficiency, temperature, dissolved oxygen saturation and pH.
Filtration in Biopharmaceutical Processes
In biomanufacturing of monoclonal antibodies, vaccines and therapeutic proteins, filtration is an essential step in this process chain. Therefore, single-use filters are used for reducing the bioburden and removing particles, and sterilizing-grade filters are utilized to perform sterile filtration in final filling. These disposable filters are already validated, presterilized and ready to use right “out of the box.” As a result, they eliminate the added costs of cleaning the housing and of validation of the cleaning procedure.
Safe Storage of Biologics
Transportation and storage of biologics are key intermediate steps in the production of biopharmaceuticals. To ensure the safety of these products across the entire process chain, these liquids are filled into sterile single-use bags and stored in specially designed tanks.
Purification of Target Proteins
After successful cell cultivation, the desired target proteins are separated by crossflow filtration from the remaining constituents of a medium. In several filtration steps, the target protein is purified until the only active pharmaceutical ingredient in the desired concentration remains. SARTOFLOW® Advanced is used in ultra-, micro- and diafiltration to purify vaccines, monoclonal antibodies or recombinant proteins. This system is ideal for flexible use in the laboratory, in process development and in clinical studies as well as for small production batches. The linear scalability of the system from 0.1 to 2.1 m2 of membrane area and its minimal loop volume of ~ 200 ml make SARTOFLOW Advanced unique.
Quality Control of Virus Filters
Biopharmaceutical companies check the filterability of their product, such as monoclonal antibodies, initially by performing lab-scale test series. In these series, they filter their product using different membrane types and check the flow rates, total throughput and binding capacity to determine the optimal membrane and filter area for their product and particular process step. During in-house quality control, the virus-retentive membrane is also routinely tested for its capacity to retain viruses.
Analysis of Cell Culture Processes
Cell cultivation is initially tested at the lab-scale level. In trial series, the parameters of the individual samples are altered, such as pH, oxygen content and temperature, to find the conditions that are most conducive to optimal cell growth. During the cultivation process, the cultures are continually sampled and analyzed.
Microbiological Quality Control in the Laboratory
In microbiological laboratories, products, such as water, food and beverage and other fluids, are tested for the presence of contamination. Any contaminating microorganisms in the sample are retained on the filter surface by membrane filtration. The membrane is then incubated on a nutrient pad set on which the microbes grow and can be counted. Only if the colony count is within the given specifications may the product be released.
Ultrapure Water in the Lab
Type I reagent-grade water is essential in any laboratory and is used in nearly every lab procedure. Whether used to clean laboratory glassware, to prepare buffers and cell culture media or to perform critical laboratory applications, such as DNA sequencing, ultrapure water must have the appropriate degree of purity in order to ensure reliable research results.