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Ion exchange chromatography of biotherapeutics: Fundamental principles and advanced approaches.
J Chromatogr A
February 2025
School of Pharmaceutical Sciences, University of Geneva, CMU - Rue Michel Servet 1, 1211 Geneva 4, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU - Rue Michel Servet 1, 1211 Geneva 4, Switzerland. Electronic address:
Ion exchange chromatography (IEX) is an important analytical technique for the characterization of biotechnology-derived products, such as monoclonal antibodies (mAbs) and more recently, cell and gene therapy products such as messenger ribonucleic acid (mRNA) and adeno-associated viruses (AAVs). This review paper first outlines the basic principles and separation mechanisms of IEX for charge variant separation of biotherapeutics, and examines the different elution modes based on salt or pH gradients. It then highlights several recent trends when applying IEX for the characterization of biotechnology-derived products, including: i) the effective use of pH gradients, ii) the improvement of selectivity by using organic solvents in the mobile phase, multi-step gradients, or by combining ion pairing and ion exchange, and iii) the increase in analytical throughput using ultra-short columns or automated screening of conditions.
View Article and Find Full Text PDFSerum Concentration-Dose Relationship and Modulation Factors in Children and Adolescents Treated with Fluvoxamine.
Pharmaceutics
June 2024
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
Introduction: Fluvoxamine is used in children and adolescents ('youths') for treating obsessive compulsive disorder (OCD) but also off-label for depressive and anxiety disorders. This study aimed to investigate the relationship between fluvoxamine dose and serum concentrations, independent correlates of fluvoxamine concentrations, and a preliminary therapeutic reference range (TRR) for youths with OCD and treatment response.
Methods: Multicenter naturalistic data of a therapeutic drug monitoring service, as well as prospective data of the 'TDM Vigil study' (EudraCT 2013-004881-33), were analyzed.
Size exclusion chromatography of biopharmaceutical products: From current practices for proteins to emerging trends for viral vectors, nucleic acids and lipid nanoparticles.
J Chromatogr A
May 2024
Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU - Rue Michel Servet 1,4, 1211 Geneva, Switzerland; School of Pharmaceutical Sciences, University of Geneva, CMU - Rue Michel Servet 1,4, 1211 Geneva, Switzerland. Electronic address:
The 21st century has been particularly productive for the biopharmaceutical industry, with the introduction of several classes of innovative therapeutics, such as monoclonal antibodies and related compounds, gene therapy products, and RNA-based modalities. All these new molecules are susceptible to aggregation and fragmentation, which necessitates a size variant analysis for their comprehensive characterization. Size exclusion chromatography (SEC) is one of the reference techniques that can be applied.
View Article and Find Full Text PDF[How could forensic psychiatry be made more attractive?].
Orv Hetil
September 2023
1 Semmelweis Egyetem, Általános Orvostudományi Kar, Pszichiátriai és Pszichoterápiás Klinika Budapest, Balassa u. 6., 1083 Magyarország.
Article Synopsis
- A recent critical shortage of forensic psychiatric experts is affecting both healthcare and the justice system, highlighting the need for solutions to attract more professionals to the field.
- The objective of the study was to identify strategies to make forensic psychiatry and the training process more appealing through an online survey targeting forensic psychiatric experts and psychiatrists.
- Key findings revealed that participants overwhelmingly suggested increasing training institutes, reducing training costs, offering free courses from the Hungarian Forensic Expert Chamber, and providing stipends to support aspiring forensic psychiatrists.
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