2009

Three Ways to Increase Laboratory Efficiency

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…

High-Throughput 96-Well Osmolality Determinations Supporting Cell Culture Process Development and Optimization

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…

Hi-Tech Components for Holistic Cultivation

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…

Advantages of Archived Standard Curves for the Quantitative Bacterial Endotoxins Test

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…

Assay Miniaturization Saves Time, Labor, and Resources to Boost Overall Efficiency and Productivity

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…

Microvolume Sample Quantitation for Bioprocessing QC, Manufacturing, and Analytical Labs

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…

Automation in Process Development

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…

Improving Peptide Mapping

Figure 1: Peptide mapping is the workhorse technique in biopharmaceutical analysis, offering the comprehensive characterization of biopharmaceutical products. Its applications include the identification of proteins based on the elution pattern of peptide fragments, the determination of posttranslational modifications, the confirmation of genetic stability, and the analysis of protein sequences when interfaced to a mass spectrometer. In a typical peptide mapping workflow, a protein is first digested with trypsin or other protease to generate peptides, which are separated by liquid chromatography,…

Setting the Stage

Much has already been written lately about addressing the so-called “downstream bottleneck(s).” A number of companies are leading the way toward developing products and platforms for reducing both the costs and the time required for downstream processing. Our task with this special issue was to provide a state-of-the-art update on these activities — but as always, within a limited number of pages allotted. The primary issue behind this bottleneck debacle is to address purification challenges posed by aggregation in cell…

Patents, Politics, and Polypeptides

Humor columnist Dave Barry once opined, “Without question, the greatest invention in the history of mankind is beer. Oh, I grant you that the wheel was also a fine invention, but the wheel does not go nearly as well with pizza.” Certainly, few biological concoctions have achieved that level of popularity — but with a little luck, your company will produce at least one invention with the potential for measurable success in its target market. But with success comes competition,…