Figure 1: Bioprocess monitoring and automatic feeding of key nutrients such as glucose and amino acids are critical to obtain optimal high productivity in cell culture systems. Here we present a complete, closed-loop system that integrates a Groton Biosystems Automated Reactor Sample System with a nutrient analyzer and a reactor control system that demonstrates a powerful, automated online, real-time feeding system. Materials and Methods A Groton Biosystems Automated Reactor Sampler (ARS-M) is connected to a four-vessel DasGip Parallel Bioreactor System…

Figure 1: The Mobius CellReady 3-L bioreactor is a single-use, stirred-tank bioreactor ideal for bench-scale cell culture. The CellReady 3-L bioreactor is preassembled and gamma irradiated, significantly reducing turnaround times typically associated with glass bioreactors. There is no need to clean, assemble, or autoclave between experiments. The CellReady 3-L bioreactor ensures maximum operational flexibility with prefitted, weldable tubing and vent filter; two sparging options; and compatibility with most standard bioreactor controller configurations. Designed to replace traditional glass, bench-scale bioreactors, the…

Figure 1: New Brunswick Scientific has developed three new versions of Supervisory Control and Data Acquisition (SCADA) software programs. These SCADA programs allow fermentation or cell culture processes to be automated, monitored, and controlled. The three packages — BioCommand® Track and Trend, BioCommand Batch Control, and BioCommand Batch Control Plus — provide a variety of tools and the flexibility needed for any process requirement. Whether you require only basic trending and batch reporting, programming for process automation and optimization, or…

Figure 1: Biological drugs are an increasingly important and growing part of the pharmaceutical industry but are associated with a number of challenges that have constrained their application. The lack of efficacy due to short protein half-life and/or poor availability is an issue that leads to a requirement for both high and frequent dosing (Figure 1). Such administration demands can result in unwanted side effects and limit the therapeutic benefits, as well as elevated patient dosing that creates an extra…

Quality control is very often perceived as the last step in manufacturing a product. But quality is not a consequence of quality testing; it must be built into the manufacturing process. At the beginning of the 21st century, the FDA Advisory Committee for Pharmaceutical Science (ACPS) began to address this problem, calling for consistent regulations in designing, analyzing, and controlling pharmaceutical manufacturing processes. As a result, process analytical technology (PAT) was developed providing a framework for innovative pharmaceutical manufacturing and…

Figure 1: The effect of prefiltration on the scalability of 0.1-m rated membrane filters is evaluated using a specific cell culture medium that showed reduced filtration throughput (in terms of L/m2) with pleated cartridges. Biopharmaceutical process developers seek to size membrane filters more accurately to improve process economics. Understanding the scalability of filters from discs to pleated cartridges has thus become important. Contradictory claims on the scale-up between different filter configurations have been made in the literature (1, 2). Recently,…

Figure 1: This protein proved to be “difficult to express” in both mammalian (CHO) and yeast (Pichia pastoris) expression platforms. In CHO cells, expression levels were very low, 1 g/L at the 96-well scale, had deletions of two proteases that when singly deleted showed marginal expression of the growth factor. When those cells are grown in a fermentor, we anticipate a further three- to five-fold increase in titer. These results powerfully demonstrate the utility of the Pfēnex Expression Technology™ toolbox…

Figure 1: Bioprocess fermentors are typically equipped with real-time monitoring devices such as temperature, pH, oxygen, or even viable cell density. The advantages of on-line over off-line measurements are easiness of use, timely results, and the possibility of immediate responses to the measured value. By contrast with the well-equipped fermentors used for production, the disposables used in bioprocess development have lacked such on-line measurement devices so far. Cultivation conditions could be monitored only by means of off-line sampling, typically performed…

SAFC Biosciences® since 1971 manufactures high quality sera, cell culture media, and specialty products for commercial firms using mammalian and insect cell culture methods to develop and produce biopharmaceuticals. SAFC Biosciences focuses on organizations involved in vaccine, human therapeutics, and animal health in all stages of development from preclinical through clinical phases I, II, and III, to commercial products. SAFC Biosciences has successful relationships with pharmaceutical, established and start-up biotechnology companies, contract research and manufacturing organizations, agricultural-related firms, and nonprofit…

Figure 1: Deployment of new GMP biomanufacturing capacity is a battle of tradeoffs (Figure 1). Push to accelerate your timetable? Cost or quality considerations must be compromised. Need to drive down total investment? Build-out time or quality must be sacrificed. As single-use technology establishes wider acceptance, certain tradeoffs may be lessened, but serious challenges remain. Figure 1: () Overcoming the limitations intrinsic to conventional biomanufacturing strategies requires a fundamental rethinking of bioproduction architecture. With the FlexFactory® biomanufacturing platform and a…