Category: <span>Research</span>

This article reports the average titers and yields currently attained with commercially manufactured biopharmaceuticals expressed by microbial systems such as E. coli and yeasts. A recent BioProcessing Journal article comparably covered results from the first phase of this study concerning historical titers and yields attained for commercial-scale biopharmaceutical production using mammalian cells (e.g., CHO). As with this prior mammalian component, public domain data concerning titers and yields attained with microbially manufactured products were obtained using all available sources.

Biologics Production Bioreactor Scale-Up Mammalian Cell Culture Manufacturing Research

Two cell disruption methods, mechanical and chemical, were applied for the recovery of a fusion protein named CIGB 550-E7, expressed on Escherichia coli grown in defined saline media. A comparison of the methods was done, and various operating parameters for each technique were optimized to obtain the maximum disruption efficiency and CIGB 550-E7 protein release. The mechanical disruption’s yield and recovery were 1.24 and 1.37 times higher than those obtained with chemical disruption. Modified conditions were assayed for the CIGB 550-E7 obtained by chemically defined media using the mechanical and chemical cell disruption methods.

Biologics Biologics Production Manufacturing Research

Traditionally, the Six Sigma framework has underpinned quality improvement and assurance in biopharmaceutical manufacturing process management. This paper proposes a neural network (NN) approach to vaccine yield classification and compares it to an existing multiple linear regression approach. As part of the Six Sigma process, this paper shows how a data mining framework can be used to extract further value and insight from the data gathered during the manufacturing process, and how insights into yield classification can be used in the quality improvement process.

Bioinformatics Biologics Biologics Production Research

Plants must be capable of responding to climatic fluctuations, diurnal rhythms, available supplies of water and nutrients, and insect attacks and infestations. To ensure such responses, plants need a network of regulating substances called phytohormones. These substances enable plants to respond to both biotic and abiotic stresses by initiating a cascade of orchestrated actions, and to trigger development-specific processes. In this article, we will discuss a highly sensitive analytical method for quantitative determination of phytohormones. The main representatives of the plant hormones are jasmonic acid (JA), cytokines, auxins, abscisic acid, salicylic acid, gibberellins, and strigolactones.

Biologics Research

Plaque assays have traditionally been a reliable way to determine the titer of a lytic virus. However, this method has several shortcomings in that it is time-consuming, labor intensive, and suffers from limited sensitivity. In this article, we describe a novel flow cytometry-based titration assay to quantify green fluorescent protein-labeled herpes simplex virus type 1 (HSV-1-GFP). Using this assay, we were able to directly quantify ten-fold dilutions of the virus in which every GFP-positive cell could be counted. In a head-to-head comparison with a traditional plaque assay, the flow cytometry assay showed a greater linear range and was accomplished in less than half the time of the plaque assay.

Bioinformatics Biologics Biologics Production Regulatory Research

This article examines two interrelated animal welfare topics: the transportation of pregnant cattle, and the collection of fetal bovine serum (FBS). The occurrence of pregnant cattle at slaughter is unavoidable because of health, management, and economic reasons, or because farmers may be unaware of their pregnancy status. Since cattle are often sold to slaughterhouses through intermediaries, the pregnancy status of the cow is usually unknown until after it has been slaughtered and the uterus exposed. In slaughterhouses where fetal blood is collected, technicians are responsible for the detection and proper handling of fetuses, making sure they remain inside the uterus until dead, or are immediately euthanized. The harvesting of fetal blood also provides a possible source of information, which upon request, may help farmers improve the management of their livestock operations. The serum industry endorses the animal welfare standards set forth by the World Organization for Animal Health (OIE), as well as all existing local and national standards relating to the transportation of pregnant cattle and the collection of fetal blood. This article concludes that there is nothing negative or unethical about collecting blood from a dead fetus. Rather it would be unethical not to utilize available fetal tissues obtained from the slaughter of pregnant cattle, especially since FBS, used as an ingredient in cell culture media, contributes greatly to the advancement of the life sciences industry, as well as the replacement and reduction of live animals used in research and testing…

Regulatory Research

How much new business does it take to add $100,000 or even $1 million to the bottom line? Even with tax deadlines looming for companies that filed extensions, there is still time to maximize the benefits of all available tax credits and incentives. A powerful tax incentive known as the research and development (R&D) tax credit is available in the United States at both the federal and state levels to help manufacturers recover a significant amount of R&D costs…

Manufacturing Research

Propagation and culturing of animal cells is fundamental to biomedical research. Over the past decade, there has been an increased demand for cell lines for usage as both research tools and models by academic and industrial scientists. Cell culture is a critical tool in such areas as cell biology, gene therapy, genomics, transcriptomics and proteomics. The increased demand for cells and cell-based assays has triggered a remarkable boost in cell culture activities, which in turn has lead to a greater incidence of misidentified and contaminated cell cultures…

Research

Fresh on the heels of Mission #3 at the stiflingly hot Death Valley National Park, the ARTEL Extreme Pipetting Expedition team looked forward to visiting the temperate and humid Olympic National Park. Known for its lush, rainforest-like conditions, Olympic is home to 266 glaciers, more than 60 miles of rugged Pacific coastline, and over 140 inches of rainfall each year. It also has the Northwest’s largest remaining acreage of undisturbed rain forests…

Research

As the ARTEL Extreme Pipetting Expedition team set out for Mission #3, only one thing was certain — it was about to get much hotter. Heading to Death Valley National Park in the desert spanning Nevada and California, the Expedition’s goal was to test the effect of dry heat on pipetted volumes. As the sun beat down and the temperature rose, the cold temperatures of Mt. Washington (Mission #1) and the mild climate at Yellowstone National Park (Mission #2) seemed like distant memories to the Expedition team…

Research