scholarly journals Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions

2020 ◽  
Vol 9 (1) ◽  
pp. 5-13 ◽  
Author(s):  
Shon Crampton ◽  
Alla Polozova ◽  
Darin Asbury ◽  
Alexis Lueras ◽  
Paul Breslin ◽  
...  
Keyword(s):  
Infusion Pump ◽  
Significant Loss ◽  
High Dose ◽  
Different Temperatures ◽  
Transportation Simulation ◽  
Post Infusion ◽  
Biological Potency ◽  
The Stability ◽  
The Impact ◽  
And Storage

Study objectives: To investigate the quality and in-use stability of diluted ABP 980 (a trastuzumab biosimilar) versus reference trastuzumab to mimic dosing in intravenous (IV) bags, transportation and extended storage prior to infusion. Methods: Low dose (70 mg; 0.3 mg/mL) and high dose (1,200 mg; 3.8 mg/mL) ABP 980 and reference trastuzumab solutions were prepared, light-protected and subjected to transportation simulation and storage (2°C–8°C or 30°C for 5 weeks, followed by 48 hours at 30°C). Stability was assessed pre- and post-transport; at Weeks 1, 2, 4, and 5; at Week 5 after 48 hours at 30°C; and pre- and post-infusion using an infusion pump. Results: Across doses and temperatures, there was little change in high molecular weight species and no detectable loss in purity. Following storage, visible particles (> 125 µm) were intermittently observed for both products, with increased subvisible particles detected with low doses. Extended storage at 2°C–8°C did not lead to any significant loss in the active molecule, with consistent biological potency across doses and temperatures for both products. Higher-dose dilutions maintained pH closer to the initial formulation specifications. Discussion: This study examined the impact of dilution, transport and extended storage at different temperatures on the stability of ABP 980 and reference trastuzumab. No major differences between the two products were observed. Conclusion: Across storage temperatures, multiple stability-indicating assays demonstrated no clinically meaningful impact to product quality and stability for both ABP 980 and reference trastuzumab, which provides assurance that ABP 980 retains stability and activity over extended storage periods.

scholarly journals Moisture sorption isotherms of castor beans. Part 1: Mathematical modeling and hysteresis

2016 ◽  
Vol 20 (8) ◽  
pp. 751-756 ◽  
Author(s):  
André L. D. Goneli ◽  
Paulo C. Corrêa ◽  
Gabriel H. H. de Oliveira ◽  
Osvaldo Resende ◽  
Munir Mauad
Keyword(s):  
Moisture Content ◽  
Sorption Isotherms ◽  
Moisture Sorption ◽  
Environmental Condition ◽  
Adsorption And Desorption ◽  
Moisture Sorption Isotherms ◽  
Different Temperatures ◽  
The Difference ◽  
The Stability ◽  
And Storage

ABSTRACT Sorption isotherms are of great importance in post-harvest procedures, especially for predicting drying and storage, which help to establish the final moisture content of the product under certain environmental condition. Hysteresis is a phenomenon that occurs due to the difference between adsorption and desorption curves, which aids the evaluation of chemical and microbiological deteriorations, indicating the stability of stored products. Moisture sorption isotherms of castor beans were determined and hysteresis was analyzed. Static gravimetric technique at different temperatures (25, 35, 45 and 55 ± 1 °C) was used. Saturated salt solutions in the range of 37-87% ± 2% were utilized to create the required controlled relative humidity environment. Equilibrium moisture content data were correlated by different mathematical models and the Modified Halsey model presented good adjustment for the data, according to statistical procedures. Hysteresis between adsorption and desorption isotherms is present over the range of 0.2-0.9 of water activity, regardless of the temperature. This phenomenon decreases with temperature increase.

Dosimetric evaluation of methyl red radiochromic film for radiation processing

2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Awad AL Zahrany ◽  
Khalid Rabaeh ◽  
Molham Eyadeh ◽  
Ahmed Basfar
Keyword(s):  
Gamma Ray ◽  
Dose Range ◽  
Absorbed Dose ◽  
Radiochromic Film ◽  
High Dose ◽  
Methyl Red ◽  
Radiation Processing ◽  
Content Type ◽  
The Stability ◽  
The Impact

Purpose The purpose of this paper is to present a radiochromic film dosimeter containing polyvinyl alcohol (PVA) matrix and various concentrations of methyl red (MR) dye for high dose measurements. Design/methodology/approach The MR-PVA films were exposed to irradiation up to 60 kGy using 60Co source of gamma ray. The ultraviolet and visible regions (UV/VIS) spectrophotometry were used to examine the optical density of pre-and post-irradiated dosimeters at 424 nm. Findings The dose sensitivity of MR-PVA films increases significantly with increasing MR dye concentrations in the dose range of 5 to 60 kGy. The impact of relative humidity, irradiation temperature, dose rate and the stability of the films has been analyzed. The overall uncertainty of the MR-PVA film dosimeter is 6.12% (Double Standard-deviation, 95% confidence level). Practical implications It was found that the MR-PVA films may be used as high dose dosimeter with an acceptable overall uncertainty in routine industrial radiation processing. Originality/value The color bleaching of irradiated MR-PVA films in terms of specific absorbance curves increases significantly with increasing absorbed dose up to 60 kGy.

scholarly journals Effects Of The Combined Heat And Cryogenic Treatment On The Stability Of Austenite In A High Co-Ni Steel

2015 ◽  
Vol 60 (3) ◽  
pp. 2131-2137 ◽  
Author(s):  
M. Gruber ◽  
S. Ploberger ◽  
G. Ressel ◽  
M. Wiessner ◽  
M. Hausbauer ◽  
...  
Keyword(s):  
Phase Distribution ◽  
Cryogenic Treatment ◽  
Tempering Temperature ◽  
Factors Affecting ◽  
Transmission Electron ◽  
Reverted Austenite ◽  
Before And After ◽  
Different Temperatures ◽  
The Stability ◽  
The Impact

Abstract The stability of austenite is one of the most dominant factors affecting the toughness properties of high Co-Ni steels such as Aermet 100 and AF1410. Thus, the aim of this work was to get a deeper understanding on the impact of combined heat and cryogenic treatment on the stability of retained and reverted austenite. In order to characterize the evolution of the phase fraction of austenite during tempering at different temperatures and times, X-ray diffraction analyses were carried out. The stability of austenite, which was formed during tempering, was analyzed with dilatometric investigations by studying the transformation behavior of the austenite during cooling from tempering temperature down to −100°C. Additionally, transmission electron microscopy investigations were performed to characterize the chemical composition and phase distribution of austenite and martensite before and after tempering.

scholarly journals The Impact of Immunomodulatory Treatment on Kappa Free Light Chains as Biomarker in Neuroinflammation

Cells ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. 842 ◽  
Author(s):  
Franz Felix Konen ◽  
Ulrich Wurster ◽  
Torsten Witte ◽  
Konstantin Fritz Jendretzky ◽  
Stefan Gingele ◽  
...  
Keyword(s):  
Intravenous Immunoglobulins ◽  
Light Chains ◽  
High Dose ◽  
Free Light Chains ◽  
High Dose Methylprednisolone ◽  
Before And After ◽  
Immune Therapies ◽  
The Stability ◽  
Sample Method ◽  
The Impact

Background: Kappa free light chains (KFLC) are a promising new biomarker to detect neuroinflammation. Still, the impact of pre-analytical effects on KFLC concentrations was not investigated. Methods: KFLC concentrations were measured in serum and cerebrospinal fluid (CSF) of patients with a newly diagnosed multiple sclerosis (MS) or clinically isolated syndrome (CIS) before (n = 42) or after therapy with high-dose methylprednisolone (n = 65). In prospective experiments, KFLC concentrations were analyzed in the same patients in serum before and after treatment with high-dose methylprednisolone (n = 16), plasma exchange (n = 12), immunoadsorption (n = 10), or intravenous immunoglobulins (n = 10). In addition, the influence of storage time, sample method, and contamination of CSF with blood were investigated. Results: Patients diagnosed with MS/CIS and treated with methylprednisolone showed significantly lower KFLC concentrations in serum as untreated patients. Repeated longitudinal investigations revealed that serum KFLC concentrations continuously decreased after each application of methylprednisolone. In contrast, other immune therapies and further pre-analytical conditions did not influence KFLC concentrations. Conclusion: Our results show prominent effects of steroids on KFLC concentrations. In contrast, various other pre-analytical conditions did not influence KFLC concentrations, indicating the stability of this biomarker.

scholarly journals Dispersibility and Storage Stability Optimization of High Dose Isoniazid Dry Powder Inhalation Formulations with L-Leucine or Trileucine

Pharmaceutics ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 24 ◽  
Author(s):  
Imco Sibum ◽  
Paul Hagedoorn ◽  
Markus P. G. Kluitman ◽  
Martijn Kloezen ◽  
Henderik W. Frijlink ◽  
...  
Keyword(s):  
Targeted Delivery ◽  
Physical Stability ◽  
Dry Powder Inhaler ◽  
High Dose ◽  
Dry Powder ◽  
Particle Dose ◽  
Moisture Protection ◽  
The Stability ◽  
Drying Conditions ◽  
And Storage

Tuberculosis is the leading cause of death from a single infectious pathogen worldwide. Lately, the targeted delivery of antibiotics to the lungs via inhalation has received increasing interest. In a previous article, we reported on the development of a spray-dried dry powder isoniazid formulation containing an L-leucine coating. It dispersed well but had poor physical stability. In this study, we aimed to improve the stability by improving the leucine coating. To this end, we optimized the spray-drying conditions, the excipient content, and the excipient itself. Using L-leucine, the tested excipient contents (up to 5%) did not result in a stable powder. Contrary to L-leucine, the stability attained with trileucine was satisfactory. Even when exposed to 75% relative humidity, the formulation was stable for at least three months. The optimal formulation contained 3% trileucine w/w. This formulation resulted in a maximum fine particle dose of 58.00 ± 2.56 mg when a nominal dose of 80 mg was dispersed from the Cyclops® dry powder inhaler. The improved moisture protection and dispersibility obtained with trileucine are explained by its amorphous nature and a higher surface enrichment during drying. Dispersion efficiency of the device decreases at higher nominal doses.

scholarly journals Cardiolipin Stabilizes and Increases Catalytic Efficiency of Carnitine Palmitoyltransferase II and Its Variants S113L, P50H, and Y479F

2021 ◽  
Vol 22 (9) ◽  
pp. 4831
Author(s):  
Beate Meinhardt ◽  
Leila Motlagh Scholle ◽  
Franziska Seifert ◽  
Martina Anwand ◽  
Markus Pietzsch ◽  
...  
Keyword(s):  
Catalytic Efficiency ◽  
Carnitine Palmitoyltransferase ◽  
Differential Scanning Fluorimetry ◽  
Different Temperatures ◽  
Functional Consequences ◽  
The Stability ◽  
Carnitine Palmitoyltransferase Ii ◽  
The Impact

Muscle carnitine palmitoyltransferase II (CPT II) deficiency is associated with various mutations in CPT2 gene. In the present study, the impact of the two CPT II variants P50H and Y479F were characterized in terms of stability and activity in vitro in comparison to wildtype (WT) and the well investigated variant S113L. While the initial enzyme activity of all variants showed wild-type-like behavior, the activity half-lives of the variants at different temperatures were severely reduced. This finding was validated by the investigation of thermostability of the enzymes using nano differential scanning fluorimetry (nanoDSF). Further, it was studied whether the protein stabilizing diphosphatidylglycerol cardiolipin (CL) has an effect on the variants. CL indeed had a positive effect on the stability. This effect was strongest for WT and least pronounced for variant P50H. Additionally, CL improved the catalytic efficiency for CPT II WT and the investigated variants by twofold when carnitine was the varied substrate due to a decrease in KM. However, there was no influence detected for the variation of substrate palmitoyl-CoA. The functional consequences of the stabilization by CL in vivo remain open.

Impact of Temperature Storage Conditions of Halyomorpha halys (Hemiptera: Pentatomidae) Eggs on Parasitism by Anastatus reduvii (Hymenoptera: Eupelmidae)

2019 ◽  
Author(s):  
Emily C Ogburn ◽  
James F Walgenbach
Keyword(s):  
Storage Conditions ◽  
Halyomorpha Halys ◽  
Host Feeding ◽  
Stink Bug ◽  
Eastern United States ◽  
Stink Bugs ◽  
Different Temperatures ◽  
Anastatus Reduvii ◽  
The Impact ◽  
And Storage

Abstract Brown marmorated stink bug, Halyomorpha halys Stål, is an invasive species of Asian origin that is an important agricultural pest in the eastern United States. Sentinel egg masses are tools used to assess the impact of natural enemies on H. halys populations. To determine the effect of host egg age and storage conditions on their susceptibility to parasitism, H. halys eggs were stored at different temperatures for different lengths of time and then exposed to Anastatus reduvii (Howard), a native natural enemy of H. halys occurring in eastern North America. For eggs stored at 15, 20, and 25°C and then exposed to A. reduvii, the number of host eggs from which parasitoid offspring emerged declined with age of eggs. Control eggs (exposed to parasitoids without being stored) and those eggs stored for only 5.5 degree-days (DD) (=0.5 days) at 25°C yielded the highest percentage of parasitoids at 88.2 and 88.3%, respectively. For eggs stored at 20 and 25°C for 7.3 DD to about 36 DD, offspring emerged from about 58 to 73% of eggs, and total parasitism (emerged + unemerged parasitoids) ranged from about 70 to 80%. Parasitoid emergence was significantly lower for host eggs stored at 15°C for comparable times at 20 and 25°C. Stink bugs nymphs hatched from <0.6% of all eggs. Parasitoid-induced host egg abortion was an important component of egg mortality caused by A. reduvii, with underdeveloped stink bug nymphs, undifferentiated cell contents, and parasitoid host feeding occurring across all storage treatments.

scholarly journals Effects of UV-Light, Temperature and Storage on the Stability and Biological Effectiveness of Some Insecticides

2012 ◽  
Vol 52 (2) ◽  
pp. 275-280 ◽  
Author(s):  
Mahmoud Soliman
Keyword(s):  
Uv Light ◽  
Immature Stages ◽  
Light Storage ◽  
Degradation Rates ◽  
Residual Level ◽  
Different Temperatures ◽  
Biological Effectiveness ◽  
The Stability ◽  
And Storage ◽  
Uv Rays

Effects of UV-Light, Temperature and Storage on the Stability and Biological Effectiveness of Some InsecticidesThe degradation and biological effectiveness of five insecticides, ES-Fenvalerate (Soumi Gold), pirimicarb (Afox), imidacloprid (Emax), buprofenzin (Ablloud) and methomyl (Methiolate) in their aqueous preparations and emulsifiable concentrates, on immature stages of whitefly insectBemisia tabaci. when exposed to UV-light, two different temperatures and daylight and dark storage after exposure intervals was studied. The results indicated the degradation rates of the five tested insecticides varied according to the chemical structure, time of exposure and wavelength of UV-rays used. Of all the five insecticides, methomyl was the most affected by UV-rays. Losses of ES-Fenvalerate, pirimicarb, imidacloprid, buprofenzin and methomyl within this period were 11.30, 14.80, 29.03, 31.83 and 39%, respectively after one hour to UV-ray exposure. A significant increase in LC50value was obtained when ES-Fenvalerate in aqueous preparation was exposed to UV-light for 6 hr. The LC50values and their confidence ranges in aqueous preparations and emulsifiable concentrates were 107.5 ppm (51.7-199.2) and 93.10 ppm (48.3-150.4). The residual level of Fenvalerate, pirimicarb, imidacloprid, buprofenzin and methomyl were 13.52, 17.54 ppm; 12.67, 15.87 ppm; 11.78, 16.47 ppm; 11.38, 14.73 ppm; and 11.36, 11.83 ppm for two days exposed to daylight and dark storage. Insecticides could be arranged according to LC50values at zero-time as follow: ES-Fenvalerate, pirimicarb, imidacloprid, buprofenzin and methomyl. The corresponding values of LC50were 3.40, 15.4, 15.6, 16.2 and 23.5 ppm for daylight storage. On the other hand, the dark storage exposure for the tested insecticides could be arranged according to LC50values as follow: ES-Fenvalerate, imidacloprid, pirimicarb, buprofenzin and methomyl. The corresponding LC50were 3.20, 14.8, 14.9, 15.9 and 21.3 ppm, respectively. In general, the amount recovered after a one day, 45°C exposure were 14.63, 12.84, 12.79, 12.14 and 11.76 ppm, for ES-Fenvalerate, pirimicarb, imidacloprid, buprofenzin and methomyl, respectively. While the amounts recovered after a three day 45°C exposure were 9.28, 8.34, 7.76, 7.72 and 5.83 ppm for ES-Fenvalerate, pirimicarb, imidacloprid, buprofenzin and methomyl, respectively. Efficiency against whitefly insect,B. tabaciimmature stages was affected when aqueous preparations of the five tested insecticides were stored at 45°C for one and three days, compared to those stored under normal condition of 25°C for the same periods of time. Generally it could be concluded that buprofenzin n and methomyl, were more affected by UV-light, storage and temperature than ES-Fenvalerate, pirimicarb, imidacloprid.

scholarly journals Impact of storage conditions and storage time on silver nanoparticles' physicochemical properties and implications for their biological effects

RSC Advances ◽  
2015 ◽  
Vol 5 (102) ◽  
pp. 84172-84185 ◽  
Author(s):  
E. Izak-Nau ◽  
A. Huk ◽  
B. Reidy ◽  
H. Uggerud ◽  
M. Vadset ◽  
...  
Keyword(s):  
Silver Nanoparticles ◽  
Physicochemical Properties ◽  
Storage Time ◽  
Biological Effects ◽  
Storage Conditions ◽  
Capping Agent ◽  
The Stability ◽  
The Impact ◽  
And Storage

A multi-parametric assessment of the impact of storage time/conditions and capping agent charge on the stability and toxicity of AgNPs showed agglomeration, dissolution, oxidation, capping agent degradation and attachment of Ag+ ions all play a role.

scholarly journals Stability of lactoferrin and lysozyme in human milk at various temperatures and duration of storage

2021 ◽  
Vol 27 (2) ◽  
Author(s):  
◽  
Sumirah Budi Pertami ◽  
Agus Setyo Utomo ◽  
Siti Nur Arifah ◽  
◽  
...  
Keyword(s):  
Human Milk ◽  
Room Temperature ◽  
Storage Time ◽  
Enzyme Linked Immunosorbent Assay ◽  
Milk Samples ◽  
Duration Of Storage ◽  
Different Temperatures ◽  
Bioactive Content ◽  
The Stability ◽  
And Storage

Introduction: Exclusive breastfeeding, especially in the first six months, is essential for infants as it provides nutrition and protection against various diseases. Colostrum, which is found in the first breast milk produced, contains various protective factors, such as lactoferrin and lysozyme. Human milk can be stored at room temperature, refrigerated, or kept frozen. Several factors affect the stability of the bioactive content in human milk, such as temperature and storage time. The aim of this study was to measure the stability of lactoferrin and lysozyme levels in human milk during the first six hours (h) at different temperatures and compare it with that of frozen human milk. Methods: Human milk samples were obtained from 11 breastfeeding mothers using certain criteria. The human milk was stored at room temperature and 4°C for 1, 3, and 6 h and classified as never frozen, while frozen human milk was stored at -20°C for 1, 3, and 6 days. Measurement of the lactoferrin and lysozyme levels was performed using enzyme-linked immunosorbent assay. Results: The results showed that storage at room temperature significantly reduced lactoferrin and lysozyme levels. Lactoferrin levels in frozen human milk did not significantly decrease during the first six days. Meanwhile, the lysozyme levels in frozen human milk decreased significantly. Conclusion: The levels of lactoferrin and lysozyme in frozen human milk stored for the first six days were more stable than those stored at room temperature and 4°C in the first 6 h.

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