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Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.
AAPS J
September 2024
Integrated Bioanalysis, AstraZeneca, Gaithersburg, MD, USA.
Development of LC-MS/MS method for quantification of Lurasidone using volumetric absorptive microsampling (VAMS); a comparative study between dried blood and plasma samples.
J Chromatogr B Analyt Technol Biomed Life Sci
August 2024
SPPSPTM, SVKM's Narsee Monjee Institute of Management Studies, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India.
Article Synopsis
- - The development of alternative sampling techniques, like microsampling (<50 µL), aims to reduce the ecological impact of traditional bioanalytical methods that use toxic reagents and create biohazardous waste.
- - An LC-MS/MS method for Volumetric Absorptive Microsampling (VAMS) was successfully created to quantify Lurasidone, showing good precision and recovery rates, and proving effective even when samples are stored at room temperature.
- - The comparison of microsampling to conventional plasma techniques demonstrated that microsampling can provide comparable results while promoting better animal welfare and environmental protection, in line with the 3Rs principle.
Neutralizing Antibody Sample Testing and Report Harmonization.
AAPS J
July 2024
Bioanalytical Sciences, REGENXBIO Inc, Rockville, Maryland, USA.
Article Synopsis
- Immunogenicity testing helps understand the immune response to protein therapies, and neutralizing antibody (NAb) assays are key to characterizing anti-drug antibody responses.
- A group of NAb assay experts has created standardized reporting recommendations to streamline communication and facilitate regulatory submissions.
- The document outlines essential components for NAb sample analysis reports, though it does not cover the interpretation of immunogenicity data related to safety and efficacy.
Feedback from the Science Café roundtables at the ninth European Bioanalysis Forum Young Scientist Symposium: optimizing the work-life balance in a bioanalytical laboratory.
Bioanalysis
August 2024
European Bioanalysis Forum, Havenlaan 86c b204, 1000, Brussels, Belgium.
As part of the European Bioanalysis Forum's continued commitment to develop young scientists beyond their scientific skills, we also focus on soft skills and a community responsibility during the Young Scientist Symposia, with the Science Café. In previous years, we have focused on topics such as sustainability (green lab) or the impact of the COVID-19 pandemic on career development. At the ninth Young Scientist Symposium, the Science Café roundtables focused on the work-life balance and how caring for it can be beneficial for both the individual and the company.
View Article and Find Full Text PDFAn industry perspective approach and control strategy for implementation of ready-to-use cells in bioassays: survey outcome and recommendations.
Biotechniques
April 2024
Gilead Sciences, Inc., 4010 Ocean Ranch Blvd, Oceanside, CA 92056, USA.
The BioPhorum Development Group is an industry collaboration enabling the sharing of common practices for the development of biopharmaceuticals. Bioassays are an important part of an analytical control system. Utilization of ready-to-use cells can increase operational flexibility and improve efficiency by providing frozen cell banks uniform stock while removing challenges associated with maintaining cultured cells.
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