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Preparation of Media and Buffers for Cell Cultivation in the Biopharmaceutical Industry
Cells need optimal ambient conditions so that they can successfully propagate. In addition to the agitation speed of a bioreactor and temperature, the dissolved oxygen saturation and pH of the medium are decisive for cell growth. Media and buffers in single-use bags equipped with a magnetic impeller assembly are stirred in large mixing tanks. Then these media are pumped through sterile tubing into the bioreactor.
Products: LevMixer® control unit, Flexel® Palletank® for LevMixer®, single-use Flexel® bag for LevMixer®, IF platform, Combics terminal, printer
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 und form - transfer process steps.
Products: FlexAct® Central Operating Module (COM)
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.
Products: BIOSTAT® CultiBag STR Plus, Palletank, Sartocheck 4plus, FlexAct®, Sartoclear® L-Drum
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.
Products: Sartobran P MaxiCap, Sartopore 2 MaxiCaps, Sartopore 2 XLG MaxiCaps, Sartopore 2 XLI MaxiCaps
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.
Products: Flexel® 3D Palletank® for weighing, Flexel® 3D Bag
Virus Inactivation by UV-C Irradiation in Biopharmaceutical Processes
To ensure the safety of biomanufactured active pharmaceutical ingredients (APIs) and to prevent contamination by viruses, various orthogonal technologies for viral clearance are required by regulatory authorities. The established technologies for viral clearance include membrane chromatography and various inactivation technologies, such as UV-C irradiation, besides classic virus filtration. Unlike classic inactivation technologies, UV-C irradiation is especially effective for small, non-enveloped viruses.
Products: UVivatec®, Filter Cartridges, Sartoflow® Alpha plus
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.
Product: SARTOFLOW® Advanced with integrated control unit
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.
Products: Virosart, Minisart
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.
Products: MSA Cubis® with Q-Grip, CultiFlask
Instrumental Analytics in the Food Industry
Sartorius offers its customers in the food and pharmaceutical industries an extensive laboratory portfolio for instrumental analytics in quality assurance and research. The Sartorius products shown are used to determine the conductivity, pH, moisture content and weight of samples, among other characteristics. Thanks to its integrated microwave dryer, the LMA 200 moisture analyzer delivers accurate results within just a few minutes and is thus the fastest alternative to the oven-drying method of moisture analysis. Laboratory balances of the Cubis® series can be custom-configured using modules and thus can be adapted to suit any individual measurement task.
Products: Cubis®, pH meters, LMA200PM moisture analyzer
Determination of the Dissolved Oxygen Content and pH of Cell Cultures
In test series, cell cultures are exposed to different basic conditions in order to determine which conditions are optimal for cell growth. The SENSOLUX® shaker tray uses its integrated sensor system to determine and monitor the pH and dissolved oxygen saturation during cultivation of animal or human cell cultures. Its non-invasive measurement technology protects the cell culture from cross-contamination.
Products: SENSOLUX® stand-alone version, SENSOLUX® EF, pH meters
Microbiological Quality Control in the Laboratory
Manufacturers of biopharmaceutical products are subject to compliance with strict quality requirements and standards. In microbiological laboratories, products, such as pharmaceuticals and cosmetics, 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 culture medium on which the microbes grow and can be counted. Only if the colony count (number of colony-forming units) is within the given specifications or tolerance limits may a batch be released.
Products: Microsart® @filter, Microsart® e.motion dispenser, Microsart® combi.jet, Microsart® e.jet, Microsart® e.motion membrane filters
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.
Products: Microsart® e.motion dispenser, Microsart® e.motion membrane filters, Microsart® maxi.vac vacuum pump, nutrient pad sets, Combisart® multi-branch manifolds, Biosart® 250 funnels
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.
Products: arium® pro