To enable subcutaneous administration of monoclonal antibodies, drug product solutions are often needed at high concentrations. A significant risk associated with high drug product concentrations is an increase in aggregate level over the shelf-life dating period. While much work has been done to understand the impact of drug product formulation on aggregation, there is limited understanding of the link between cell culture process conditions and soluble aggregate growth in drug product. During cell culture process development, soluble aggregates are often measured at harvest using cell-free material purified by Protein A chromatography. In the work reported here, cell culture media components were evaluated with respect to their impact on aggregate levels in high concentration solution drug product during accelerated stability studies. Two components, cysteine and ferric ammonium citrate, were found to impact aggregate growth rates in our current media (version 1) leading to the development of new chemically defined media and concentrated feed formulations. The new version of media and associated concentrated feeds (version 2) were evaluated across four cell lines producing recombinant IgG4 monoclonal antibodies and a bispecific antibody. In all four cell lines, the version 2 media reduced aggregate growth over the course of a 12 week accelerated stability study compared with the version 1 media, although the degree to which aggregate growth decreased was cell line dependent. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:998-1008, 2016.
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http://dx.doi.org/10.1002/btpr.2289 | DOI Listing |
PLoS One
January 2025
Institute of Natural Antioxidants and Anti-Inflammation, Dali University, Dali, Yunnan, China.
Oxidative damage, oxidative inflammation, and a range of downstream diseases represent significant threats to human health. The application of natural antioxidants and anti-inflammatory agents can help prevent and mitigate these associated diseases. In this study, we aimed to investigate the effectiveness of walnut green husk (WNGH) as an antioxidant and anti-inflammatory agent in an in vitro setting.
View Article and Find Full Text PDFPLoS One
January 2025
School of Public Health, Anhui University of Science and Technology, Hefei, China.
A number of studies demonstrate the therapeutic effectiveness of Radix Bupleuri (RB) and Hedysarum Multijugum Maxim (HMM) in treating liver fibrosis, but the exact molecular mechanisms remain unclear. This study aims to explore the mechanism of RB-HMM drug pairs in treating liver fibrosis by using network pharmacology, bioinformatics, molecular docking, molecular dynamics simulation technology and in vitro experiments. Totally, 155 intersection targets between RB-HMM and liver fibrosis were identified.
View Article and Find Full Text PDFMicrob Biotechnol
January 2025
Laboratory of Microbiology, Institute of Biology, University of Neuchatel, Neuchatel, Switzerland.
The inadequate removal of pharmaceuticals and personal care products (PPCPs) by traditional wastewater treatment plants (WWTPs) poses a significant environmental and public health challenge. Residual PPCPs find their way into aquatic ecosystems, leading to bioaccumulation in aquatic biota, the dissemination of antibiotic resistance genes (ARGs), and contamination of both water sources and vegetables. These persistent pollutants can have negative effects on human health, ranging from antibiotic resistance development to endocrine disruption.
View Article and Find Full Text PDFActa Bioeng Biomech
September 2024
Faculty of Materials Science and Engineering, Warsaw University of Technology, Warsaw, Poland.
The aim of the study was to investigate the influence of the nitrocarburizing process carried out in low temperature plasma using the active screen at 440 °C on the structure and physicochemical properties of the 316LVM steel. In the paper, results of micro-structure and phase composition of the layers, roughness, and surface wettability, potentiodynamic pitting corrosion resistance, penetration of ions into the solution as well as biological tests were present. The studies were conducted for the samples of both mechanically polished and nitrocarburized surfaces, after sterilization, and exposure to the Ringer's solution.
View Article and Find Full Text PDFJAMA Netw Open
January 2025
Amazon Health Services, Seattle, Washington.
Importance: Medication nonadherence imposes high morbidity, mortality, and costs but is challenging to address given its multiple causes. Subscription models are increasingly used in health care to encourage healthy behaviors; in January 2023, Amazon Pharmacy launched RxPass, a subscription program offering Amazon Prime members (hereafter, company members) in 45 states access to 60 common generic medications for a flat $5 monthly fee.
Objective: To evaluate the associations of program enrollment with medication refills, days' supply, and out-of-pocket costs.
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