Efforts to develop a vaccine for the elimination of malaria include the use of carrier proteins to assemble monomeric antigens into nanoparticles to maximize immunogenicity. Recombinant ExoProtein A (EPA) is a detoxified form of Pseudomonas aeruginosa Exotoxin A which has been used as a carrier in the conjugate vaccine field. A pilot-scale process developed for purification of EPA yielded product that consistently approached a preset upper limit for host cell protein (HCP) content per human dose. To minimize the risk of bulk material exceeding the specification, the purification process was redeveloped using mixed-mode chromatography resins. Purified EPA derived from the primary and redeveloped processes were comparable following full biochemical and biophysical characterization. However, using a process specific immunoassay, the HCP content was shown to decrease from a range of 0.14-0.24% w/w of total protein to below the level of detection with the revised process. The improved process reproducibly yields EPA with highly similar quality characteristics as the original process but with an improved profile for the HCP content.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6525083 | PMC |
| http://dx.doi.org/10.1016/j.vaccine.2018.09.037 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Determining the impact of mobile-based self-care applications on reducing anxiety in healthcare providers: a systematic review.
BMC Med Inform Decis Mak
January 2025
Faculty of Management and Medical Information Sciences, Kerman University of Medical Sciences, Kerman, Iran.
Background: Healthcare providers (HCP) face various stressful conditions in hospitals that result in the development of anxiety disorders. However, due to heavy workloads, they often miss the opportunity for self-care. Any effort to diminish this problem improves the quality of Healthcare providers and enhances patient safety.
View Article and Find Full Text PDFThe engagement of healthcare providers in implementing the selfBACK randomised controlled trial - A mixed-methods process evaluation.
Digit Health
January 2025
The National Research Centre for The Working Environment, Copenhagen, Denmark.
Background: People with low back pain (LBP) are often recommended to self-manage their condition, but it can be challenging without support. Digital health interventions (DHIs) have shown promise in supporting self-management of LBP, but little is known about healthcare providers' (HCPs) engagement in implementing these.
Aims: We aimed to examine HCPs' engagement in patient recruitment for the selfBACK app clinical trial and explore their perceptions of the app.
Objectives: The Assessment of Burden of Chronic Conditions (ABCC) tool is developed to facilitate a personalised approach to care through assessment and visualisation of a patient's experienced burden of disease, and integrating this in the conversation based on shared decision-making and individualised care plans. An indispensable step in the implementation process is an understanding of the context. The aim of this study is to perform a context analysis to identify barriers and facilitators to the implementation of the ABCC tool by healthcare providers (HCPs) in Dutch primary care.
View Article and Find Full Text PDFContent Validity of the Friedreich Ataxia Rating Scale in Patients with Spinocerebellar Ataxia.
Neurol Ther
January 2025
Biohaven Pharmaceuticals, Inc., 215 Church Street, New Haven, CT, 06510, USA.
Introduction: The Friedreich Ataxia Rating Scale-Activities of Daily Living (FARS-ADL) is a validated and highly utilized measure for evaluating patients with Friedreich Ataxia. While construct validity of FARS-ADL has been shown for spinocerebellar ataxia (SCA), content validity has not been established.
Methods: Individuals with SCA1 or SCA3 (n = 7) and healthcare professionals (HCPs) with SCA expertise (n = 8) participated in qualitative interviews evaluating the relevance, clarity, and clinical meaningfulness of FARS-ADL for assessment of individuals with SCA.
Automated, Quantitative Capillary Western Blots to Analyze Host Cell Proteins in COVID-19 Vaccine Produced in Vero Cell Line.
Vaccines (Basel)
December 2024
Analytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
Background/objectives: Host cell protein (HCP) content is a major attribute for biological and vaccine products that must be extensively characterized prior to product licensure. Enzyme Linked Immunosorbent Assay (ELISA) and Mass Spectrometry (MS) are conventional methods for quantitative host cell protein analysis in biologic and vaccine products. Both techniques are usually very tedious, labor-intensive, and challenging to transfer to other laboratories.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!