A robust, economical process should leverage proven technology, yet be flexible enough to adopt emerging technologies which show significant benefit. Antibody and Fc-fusion processes may capitalize on the high selectivity of an affinity capture step by reducing the total number of chromatographic steps to 2. Risk associated with this approach stems from the potentially increased time frame needed for process development as well as unforeseen changes in impurity profile during first scale-up of drug substance (DS) for animal toxicology and clinical phase I trials (FIH) production, which could challenge a two-step process to the point of failure. Two different purification strategies were pursued during process development for an FIH process of a dAB-Fc fusion protein. A two-step process was compared to a three-step process. The two-step process leveraged additives to maximize impurity reduction during affinity capture. While wash additives in combination with a mixed mode chromatography met all impurity reduction requirements, HCP levels were still higher as compared to the three-step process. The three-step process was implemented for manufacture of clinical material to mitigate risk.
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http://dx.doi.org/10.1002/bit.25561 | DOI Listing |
Sci Rep
January 2025
Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, People's Republic of China.
Previous observational studies have reported inconsistent associations between nut consumption and cardiovascular diseases (CVD). This study aims to identify the causal relationship between different types of nuts consumption and CVD, and to quantify the potential mediating effects of cardiometabolic factors. We utilized Genome-Wide Association Study (GWAS) data to assess the causal effects of nut consumption on CVD using two-sample Mendelian randomization (MR) and a two-step MR analysis.
View Article and Find Full Text PDFBMC Health Serv Res
January 2025
Logistics Education (LEED) at Kühne Foundation, Hamburg, Germany.
Background: To ensure the complete traceability of healthcare commodities, robust end-to-end data management protocols are needed for the supply chain. In Ethiopia, digital tools like Dagu-2 are used in the lower levels of the healthcare supply chain. However, there is a lack of information regarding the implementation status, factors, and challenges of Dagu-2, as it is a recent upgrade from the offline Dagu-1 application.
View Article and Find Full Text PDFInt J Biol Macromol
January 2025
SKL of Marine Food Processing & Safety Control, National Engineering Research Center of Seafood, Collaborative Innovation Center of Seafood Deep Processing, Liaoning Province Key Laboratory for Marine Food Science and Technology, School of Food Science and Technology, Dalian Polytechnic University, Dalian 116034, People's Republic of China. Electronic address:
Corn starch inclusion complexes of alkyl gallates (typical phenololipid representatives), including stearyl gallate, dodecyl gallate, octyl gallate, and hexadecyl gallate, were synthesized by using a heat treatment method. Such inclusion complexes exhibited significantly improved two-step release properties for gallic acid. In other words, gallic acid was generated via the breakdown of alkyl gallates that were released from inclusion complexes in an everted rat intestinal sac model, as determined by HPLC-UV analysis.
View Article and Find Full Text PDFAngew Chem Int Ed Engl
January 2025
Shanghai Normal University, Chemistry, No. 100, Guilin Road, 200234, Shanghai, CHINA.
The use of precious metals (PMs) in many areas, such as printed circuit boards, catalysts, and target drugs, is increasing due to their unique physical and chemical properties, but their recovery remains a great challenge in terms of zero-valent PMs as final product. We report a highly hydrophilic carbon dot (CD) as reductant (electron donor), the defects in CD served as efficient active sites for zero-valent PMs recovery with an electron-donating capacity is ~1.7 mmol g-1.
View Article and Find Full Text PDFConf Proc (IEEE Colomb Conf Commun Comput)
August 2024
School of Electronic and Electrical Engineering, Sungkyunkwan University, South Korea.
A new pneumonia detection method is proposed to provide both pneumonia detection in respiratory sound signals and wheeze and crackle discrimination when pneumonia episodes are detected. In the proposed method, two-step hierarchy, classifying pneumonia in the first step and discriminating wheezing and crackling in the second step, is considered; the conventional pneumonia detection method is modified to improve pneumonia detection performance, while wheezing and crackling discrimination functionality is added to facilitate the application of appropriate remedies for each case. We used resampling techniques to address the imbalance in the ICBHI pneumonia dataset.
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