In recent years, the stability of biotherapeutics in vivo has received increasing attention. Assessing the stability of biotherapeutics in serum may support the selection of adequate molecule candidates. In our study, we compared the physical stability of 8 different monoclonal antibodies (mAbs) in phosphate-buffered saline (PBS) and human serum. mAbs were Alexa Fluor 488-labeled and characterized with respect to fragmentation, aggregation, and proteinaceous particle formation. Samples were analyzed using size-exclusion chromatography, light obscuration, and flow imaging. In addition, novel methods such as flow cytometry and fluorescence microscopy were applied. mAbs were selected based on their hydrophobicity and isoelectric point. All mAbs studied were inherently less stable in human serum as compared to PBS. Particle size and particle counts increased in serum over time. Interestingly, certain mAbs showed significant levels of fragmentation in serum but not in PBS. We conclude that PBS cannot replicate the physical stability measured in serum. The stability of labeled mAbs in human serum did not correlate with their hydrophobicity and isoelectric point . Serum stability significantly differed amongst the tested mAbs.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejpb.2020.04.014DOI Listing

Publication Analysis

Top Keywords

human serum
16
physical stability
12
serum
9
mabs
8
serum pbs
8
stability biotherapeutics
8
hydrophobicity isoelectric
8
isoelectric point
8
serum stability
8
stability
7

Similar Publications

Background/objectives: Sepsis-related acute kidney injury (SA-AKI) is a severe condition characterized by high mortality rates. The utility of the sCAR (secrum creatinine/albumin) and LAR (Lactate dehydrogenase/albumin) as diagnostic markers for persistent severe SA-AKI remains unclear.

Methods: We acquired training set data from the MIMIC-IV database and validation set data from the First Affiliated Hospital of Harbin Medical University.

View Article and Find Full Text PDF

Assessment of various etiological factors for oral squamous cell carcinoma in non-habit patients- a cross sectional case control study.

BMC Oral Health

January 2025

Clinical Genetics Lab, Centre for Cellular and Molecular Research, Saveetha Dental College and Hospitals, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, 162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, 600077, India.

Background: Oral squamous cell carcinoma (OSCC) is one of the most prevalent oral cancers in the world. The major etiological factors are considered to be tobacco and alcohol. However, the etiological factors for non-habit associated oral squamous cell carcinoma (NHOSCC) remains an enigma.

View Article and Find Full Text PDF

Objective: We aimed to compare highly purified human menopausal gonadotropin (hp-hMG) and recombinant follicle stimulating hormone (rFSH) in short antagonist in vitro fertilization (IVF) cycles of patients with poor ovarian reserve (POR). Limited research exists on this comparison in short antagonist cycles for this patient group.

Materials And Methods: This retrospective cohort study involved 165 POR patients aged 18-45 years who underwent IVF between 2018 and 2022.

View Article and Find Full Text PDF

Amidine-functionalized aggregation-induced emission luminogen and a 3D-printed digital sensor platform for ultrafast and visual detection of heparin.

Anal Chim Acta

February 2025

College of Chemistry, Henan Joint International Research Laboratory of Green Construction of Functional Molecules and Their Bioanalytical Applications, Food Laboratory of Zhongyuan, Zhengzhou University, Zhengzhou, 450001, China.

Background: Heparin is a widely used anticoagulant in clinic. However, improper dosing can increase the risk of thromboembolic events, potentially leading to life-threatening complications. Clinic monitoring of heparin is very important for its use safety.

View Article and Find Full Text PDF

Background: The buildup of methylparaben (MP), a broad-spectrum antimicrobial preservative with endocrine-disrupting properties, in environmental sources, especially aquatic systems, has become a significant concern due to its adverse health effects, including allergic reactions, promoting the risk of developing cancer, and inducing reproductive disorders. Hence, introducing inexpensive and easy-to-use monitoring devices for rapid, selective, and sensitive detection and quantification of MP is highly desirable. In this context, electrochemical platforms have proven to be attractive options due to their remarkable features, such as ease of fabrication and use, short response time, and acceptable sensitivity, accuracy, and selectivity.

View Article and Find Full Text PDF

Want 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!