Figure 1: Every cell line has unique nutritional requirements that must be properly balanced to achieve peak performance. However, production demands and tight timelines can make it challenging to conduct a base medium optimization for each individual cell line. To address this issue, BD has developed Select CD1000, a new, chemically defined platform medium using the proven methods of the BD AutoNutrient™ Media Design Service (AMDS) including design of experiments (DOEs) developed specifically for biopharmaceutical cell lines. BD Select CD1000…

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines or tube sets that use single-use connectors and filters to…

To reduce scale-up costs and facility capital expenses, many biotechnology companies are transitioning their stainless steel infrastructure to single-use or disposable systems. As single-use bioreactors have matured, their market acceptance has rapidly expanded. The move to disposables is in many instances driven by reduction in sterilization and cleaning requirements, improved plant flexibility for multiproduct manufacturing, reduced product changeover costs, and faster time to market for new products. To fully enable the single-use paradigm, the automation software, hardware, and single-use sensors…

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:   Millipore Corporation’s new ChromaSorb membrane adsorber uses an innovative membrane-based anion exchanger to perform robust impurity clearance at a wide range of salt concentrations. This feature enables users to improve their process economics by eliminating the downstream bottleneck of buffer tank capacity inherent with the use of other membrane adsorbers, as well as traditional resin chromatography. ChromaSorb membrane adsorber provides enhanced process flexibility and efficiency and a smaller manufacturing footprint than traditional anion resins and…

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…