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…

Equipment automation is the key to the emerging needs of laboratory efficiency. Automation reduces the risk of manual mistakes, minimizes experimental repetitions, and saves material. This retains lower operation costs, increases efficiency, and eases factorial-designed experiment approaches, such as design of experiments (DoE). Automated laboratory processes combined with comprehensive data management programs open the way into laboratory- and site-spanning information networks. With its Parallel Bioreactor System, DASGIP supports laboratory automation in microbiology and cell culture: It offers excellent opportunities for…

As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship between cells and media. Background…

Bioengineering AG looks back at over 35 years of experience in the planning and construction of biotechnological plants. Holistic solutions have become the status quo: from inoculation to harvest, from feed line to CIP-system, and from automation to validation. Because we do not want to limit our know-how to customers fermenting with Bioengineering equipment, we made components for all process steps available as single parts. To support progress in biotechnological processes, we also develop custom-made components for special applications. Operational…

Figure 1: The bacterial endotoxins test (BET) is required for most parenteral drugs and medical devices that come into contact with the human bloodstream. Limulus amebocyte lysate (LAL) derived from horseshoe crabs is used for the BET, and several methodologies have been developed. Popular quantitative LAL techniques are the kinetic turbidimetric assay (KTA) and the kinetic chromogenic assay (KCA). It is, however, well known that the endotoxin standards used in both those assays are profoundly influenced by the techniques and…

ELISA-based sandwich assays have been a traditional workhorse across the drug discovery continuum for many years, but they have significant limitations. Gyros® offers a more efficient solution for performing high-throughput, automated immunoassays on a miniaturized, fluorescence-based platform. A head-to-head comparison of the microfluidics-based Gyrolab® technology and ELISA demonstrates clear distinctions: Speed — Gyrolab yields assay results within 1–1.5 hours (including sample preparation), whereas ELISA can take a full day to test only a few samples Dynamic range — Gyrolab provides…

In industries where implementation of process analytical technology (PAT) is bringing significant benefits and improvements to many processes, any new supporting technology that helps manufacturing efficiency and lowers production cycle time is often adopted in various functional areas throughout the organization. Bioprocessing operations often need to determine nucleic acid or protein concentrations reliably and with fast sample turn-around time at various stages during manufacturing. A common practice today is UV-Vis absorbance spectroscopy using conventional cuvette-based spectrophotometers. However, a novel approach…

Figure 1: Overcoming the bottleneck is a key statement often heard in the context of bioprocessing. Acceleration of both up- and downstream processes have therefore become a general need in the biopharmaceutical industry. Not only because this will release resources to comply with the increasing numbers of drug candidates, but also because this will shorten the time-to-market, giving more time to realize a return on investment before the patent expires. Thus there is a need to apply new innovative methods…