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Evidence for stability of cardiac troponin T concentrations measured with a high sensitivity TnT test in serum and lithium heparin plasma after six-year storage at -80 °C and multiple freeze-thaw cycles.
Clin Chem Lab Med
October 2024
Department of Clinical Chemistry and Laboratory Medicine, 4501 Leiden University Medical Center, Leiden, the Netherlands.
Objectives: As high-sensitivity cardiac troponin T (hs-cTnT) is making the transition from diagnostic to prognostic use, a long-term stability study of 5th generation hs-cTnT according to EFLM CRESS recommendations was set up for investigation of frozen clinical specimens (two matrices).
Methods: Study samples collected in serum tubes and lithium heparin tubes with gel from patients admitted for suspected minor myocardial damage were measured directly after completion of the study (0 years), and after 3-year and 6-year storage at -80 °C, and recovery of hs-cTnT concentrations after long-term storage (%hs-cTnT concentration compared to 0-year) was calculated. Hs-cTnT changes were also compared to decisive delta changes, such as the ones proposed in the ESC NSTEMI 0 h/1 h algorithm (<3 or >5 ng/L for ruling out and ruling in suspected NSTEMI patients).
Impact of surfactant raw material variability on extrudate clarity appearance (transparency) in HME continuous manufacturing.
Pharm Dev Technol
September 2024
AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
The appearance of an extrudate formulation was monitored during hot-melt extrusion (HME) continuous manufacturing over 3 days. The formulation matrix consisted of a polymeric component, copovidone, and a low molecular weight surfactant, polysorbate 80. Based on studies prior to the continuous manufacturing, the desired appearance of the target extrudate is translucent.
View Article and Find Full Text PDFDrug deconjugation-assisted peptide mapping by LC-MS/MS to identify conjugation sites and quantify site occupancy for antibody-drug conjugates.
J Pharm Biomed Anal
June 2024
Mass Spectrometry Center of Excellence, Analytical Sciences, WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai 200131, China. Electronic address:
Antibody-drug conjugates (ADCs) are a heterogeneous mixture of conjugated species with varied drug loadings. Depending on conjugation sites, linkers and drugs can exhibit different stability as influenced by the solvent-accessibility and local charge, resulting in different ADC efficacy, pharmacokinetics, and toxicity. Conjugation site analysis is critical for ADC structural characterization to assure product quality and consistency.
View Article and Find Full Text PDFChanges in the cis-trans isomer selectivity of a reversed-phase liquid chromatography column during use with acidic mobile phase conditions.
J Chromatogr A
October 2023
Department of Chemistry, Gustavus Adolphus College, 800W College Ave, St Peter, MN 56082 USA. Electronic address:
Article Synopsis
- * Issues such as lot-to-lot variability and changes in stationary phase chemistry can affect the reliability of RPLC methods, leading to inconsistent results in practical applications.
- * The study investigated how the Hydrophobic Subtraction Model (HSM) could help explain variations in selectivity, particularly focusing on the selectivity differences between cis-trans isomers, revealing that the HSM may not fully account for these disparities.
Size exclusion chromatography for screening yeastolate used in cell culture media.
J Biotechnol
November 2023
Nanoscale BioPhotonics Laboratory, University of Galway, H91 CF50 Galway, Ireland. Electronic address:
Yeastolate is often used as a media supplement in industrial mammalian cell culture or as a major media component for microbial fermentations. Yeastolate variability can significantly affect process performance, but analysis is technically challenging because of its compositional complexity. However, what may be adequate for manufacturing purposes is a fast, inexpensive screening method to identify molecular variance and provide sufficient information for quality control purposes, without characterizing all the molecular components.
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