Study of aggregation in therapeutic monoclonal antibodies subjected to stress and long-term stability tests by analyzing size exclusion liquid chromatographic profiles

2018 ◽  
Vol 118 ◽  
pp. 511-524 ◽  
Author(s):  
José Hernández-Jiménez ◽  
Antonio Martínez-Ortega ◽  
Antonio Salmerón-García ◽  
José Cabeza ◽  
José Carlos Prados ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Size Exclusion ◽  
Stability Tests ◽  
Term Stability ◽  
Long Term Stability ◽  
Therapeutic Monoclonal Antibodies ◽  
Liquid Chromatographic ◽  
Chromatographic Profiles

scholarly journals Stability Assessment of Four Chimeric Proteins for Human Chagas Disease Immunodiagnosis

Biosensors ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 289
Author(s):  
Paola Alejandra Fiorani Celedon ◽  
Leonardo Maia Leony ◽  
Ueriton Dias Oliveira ◽  
Natália Erdens Maron Freitas ◽  
Ângelo Antônio Oliveira Silva ◽  
...  
Keyword(s):  
Chagas Disease ◽  
Structural Integrity ◽  
Structural Characteristics ◽  
Control Group ◽  
Stability Tests ◽  
Adverse Conditions ◽  
Term Stability ◽  
Long Term Stability

The performance of an immunoassay relies on antigen-antibody interaction; hence, antigen chemical stability and structural integrity are paramount for an efficient assay. We conducted a functional, thermostability and long-term stability analysis of different chimeric antigens (IBMP), in order to assess effects of adverse conditions on four antigens employed in ELISA to diagnose Chagas disease. ELISA-based immunoassays have served as a model for biosensors development, as both assess molecular interactions. To evaluate thermostability, samples were heated and cooled to verify heat-induced denaturation reversibility. In relation to storage stability, the antigens were analyzed at 25 °C at different moments. Long-term stability tests were performed using eight sets of microplates sensitized. Antigens were structurally analyzed through circular dichroism (CD), dynamic light scattering, SDS-PAGE, and functionally evaluated by ELISA. Data suggest that IBMP antigens are stable, over adverse conditions and for over a year. Daily analysis revealed minor changes in the molecular structure. Functionally, IBMP-8.2 and IBMP-8.3 antigens showed reactivity towards anti-T. cruzi antibodies, even after 72 h at 25 °C. Long-term stability tests showed that all antigens were comparable to the control group and all antigens demonstrated stability for one year. Data suggest that the antigens maintained their function and structural characteristics even in adverse conditions, making them a sturdy and reliable candidate to be employed in future in vitro diagnostic tests applicable to different models of POC devices, such as modern biosensors in development.

scholarly journals Comparison of the Efficacy of Two Novel Antitubercular Agents in Free and Liposome-Encapsulated Formulations

2021 ◽  
Vol 22 (5) ◽  
pp. 2457
Author(s):  
Nikoletta Kósa ◽  
Ádám Zolcsák ◽  
István Voszka ◽  
Gabriella Csík ◽  
Kata Horváti ◽  
...  
Keyword(s):  
Cellular Uptake ◽  
Drug Carrier ◽  
Antimycobacterial Activity ◽  
Size Exclusion ◽  
In Silico Docking ◽  
Term Stability ◽  
Long Term Stability

Tuberculosis is one of the top ten causes of death worldwide, and due to the appearance of drug-resistant strains, the development of new antituberculotic agents is a pressing challenge. Employing an in silico docking method, two coumaran (2,3-dihydrobenzofuran) derivatives—TB501 and TB515—were determined, with promising in vitro antimycobacterial activity. To enhance their effectiveness and reduce their cytotoxicity, we used liposomal drug carrier systems. Two types of small unilamellar vesicles (SUV) were prepared: multicomponent pH-sensitive stealth liposome (SUVmixed) and monocomponent conventional liposome. The long-term stability of our vesicles was obtained by the examination of particle size distribution with dynamic light scattering. Encapsulation efficiency (EE) of the two drugs was determined from absorption spectra before and after size exclusion chromatography. Cellular uptake and cytotoxicity were determined on human MonoMac-6 cells by flow cytometry. The antitubercular effect was characterized by the enumeration of colony-forming units on Mycobacterium tuberculosis H37Rv infected MonoMac-6 cultures. We found that SUVmixed + TB515 has the best long-term stability. TB515 has much higher EE in both types of SUVs. Cellular uptake for native TB501 is extremely low, but if it is encapsulated in SUVmixed it appreciably increases; in the case of TB515, quasi total uptake is accessible. It is concluded that SUVmixed + TB501 seems to be the most efficacious antitubercular formulation given the presented experiments; to find the most promising antituberculotic formulation for therapy further in vivo investigations are needed.

Results of Long-Term Stability Tests Performed for the Eutectics Co–C and Pt–C

2011 ◽  
Vol 32 (7-8) ◽  
pp. 1719-1731 ◽  
Author(s):  
T. Wang ◽  
C. Bai ◽  
W. Dong ◽  
Z. Yuan ◽  
P. Bloembergen ◽  
...  
Keyword(s):  
Stability Tests ◽  
Term Stability ◽  
Long Term Stability

scholarly journals Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1695
Author(s):  
Nicole Härdter ◽  
Tim Menzen ◽  
Gerhard Winter
Keyword(s):  
Monoclonal Antibodies ◽  
Gas Permeability ◽  
Drug Product ◽  
Mechanical Shock ◽  
Smart Packaging ◽  
Term Stability ◽  
Long Term Stability ◽  
Freeze Dried ◽  
Over Time

Primary containers made of cyclic olefin polymer (COP) have recently gained attention since they may overcome several risks and shortcomings of glass containers as they exhibit a high break resistance, biocompatibility, and homogeneous heat transfer during lyophilization. On the downside, COP is more permeable for gases, which can lead to an ingress of oxygen into the container over time. Since oxidation is an important degradation pathway for monoclonal antibodies (mAbs), the continuous migration of oxygen into drug product containers should be avoided overall. To date, no long-term stability studies regarding lyophilizates in polymer vials have been published, potentially because of the unbearable gas permeability. In this study, we demonstrate that after lyophilization in COP vials and storage of these vials in aluminum pouches together with combined oxygen and moisture absorbers (“smart packaging”), oxidation of two lyophilized therapeutic antibodies was as low as in glass vials due to the deoxygenated environment in the pouch. Nevertheless, active removal of oxygen from the primary container below the initial level over time during storage in such “smart” secondary packaging was not achieved. Furthermore, residual moisture was controlled. Overall, the smart packaging reveals a promising approach for long-term stability of biopharmaceuticals; in addition to COP’s known benefits, stable, low oxygen and moisture levels as well as the protection from light and cushioning against mechanical shock by the secondary packaging preserve the sensitive products very well.

Accelerated hydrothermal ageing of Pd/Al2O3 for catalytic combustion of ventilation air methane

2015 ◽  
Vol 5 (8) ◽  
pp. 4008-4016 ◽  
Author(s):  
Adi Setiawan ◽  
Jarrod Friggieri ◽  
Glenn Bryant ◽  
Eric M. Kennedy ◽  
Bogdan Z. Dlugogorski ◽  
...  
Keyword(s):  
Catalytic Combustion ◽  
Catalyst Deactivation ◽  
Stability Tests ◽  
Term Stability ◽  
Methane Gas ◽  
Long Term Stability

In this report, the characteristics of Pd/Al2O3 catalyst after long-term stability tests in catalytic combustion of simulated ventilation air methane gas were investigated with the objective of understanding catalyst deactivation phenomena.

Sign in / Sign up

Export Citation Format

Share Document