scholarly journals The Influence of Moisture Content and Temperature on the Long-Term Storage Stability of Freeze-Dried High Concentration Immunoglobulin G (IgG)

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 303 ◽  
Author(s):  
Arnold Duralliu ◽  
Paul Matejtschuk ◽  
Paul Stickings ◽  
Laura Hassall ◽  
Robert Tierney ◽  
...  

High protein concentration products for targeted therapeutic use are often freeze-dried to enhance stability. The long-term storage stability of freeze-dried (FD) plasma-derived Immunoglobulin G (IgG) from moderate to high concentrations (10–200 mg/mL) was assessed. Monomer content, binding activity and reconstitution times were evaluated over a 12-month period under accelerated and real-term storage conditions. In the first case study it was shown that FD IgG from 10 to 200 mg/mL had minimal monomer/activity losses at up to ambient temperature after 12 months of storage. However, at 45 °C the sucrose-to-protein ratio played a significant impact on IgG stability above 50 mg/mL. All IgG concentrations witnessed moisture ingress over a 12-month period. The impact of moisture ingress from environmental exposure (between 0.1% and 5% w/w moisture) for IgG 50 mg/mL was assessed, being generated by exposing low moisture batches to an atmospheric environment for fixed time periods. Results showed that at −20 °C and 20 °C there was no significant difference in terms of monomer or antigen-binding activity losses over 6 months. However, at 45 °C, there were losses in monomer content, seemingly worse for higher moisture content samples although model binding activity indicated no losses. Finally, the difference between a low moisture product (0.1–1% w/w) and a moderately high moisture (3% w/w) product generated by alternative freeze-drying cycles, both stoppered under low oxygen headspace conditions, was evaluated. Results showed that at −20 °C and 20 °C there was no difference in terms of binding activity or monomer content. However, at 45 °C, the low moisture samples had greater monomer and binding activity losses than samples from the highest moisture cycle batch, indicating that over-drying can be an issue.

ACS Omega ◽  
2020 ◽  
Vol 5 (42) ◽  
pp. 27171-27179 ◽  
Author(s):  
Indika K. Warnakula ◽  
Afshin Ebrahimpour ◽  
Sun Yi Li ◽  
Ramesha D. Gaspe Ralalage ◽  
Chathuranga C. Hewa-Rahinduwage ◽  
...  

Author(s):  
Ziedonis Miklašēvičs

The methodology in Latvia forest industry provide to determine the quality of energy chips only in long- term storage places before selling. Due to the lack of hard empirical data about the quality parameters of energy chips in different phases of manufacturing process, this research paper consists of: - the identification and analyses of the factors that influenced the values of energy chips quality features such as: bulk density, moisture content, ash content, higher and lower heating value according to actual moisture content and per dry mass of the chips; - the methodology for determination the quality parameters of energy chips by analysis the wood moisture content and by choice the method of the manufacturing of energy chips.


2004 ◽  
Vol 93 (10) ◽  
pp. 2609-2623 ◽  
Author(s):  
Derrick S. Katayama ◽  
Carol F. Kirchhoff ◽  
Carrie M. Elliott ◽  
Robert E. Johnson ◽  
Jeffry Borgmeyer ◽  
...  

2018 ◽  
Vol 1 (5) ◽  
pp. 2184-2194 ◽  
Author(s):  
Jie Feng ◽  
Yingyue Zhang ◽  
Simon A. McManus ◽  
Kurt D. Ristroph ◽  
Hoang D. Lu ◽  
...  

Energy ◽  
2019 ◽  
Vol 186 ◽  
pp. 115882 ◽  
Author(s):  
Wenfei Cai ◽  
Ning Kang ◽  
Moon Ki Jang ◽  
Chen Sun ◽  
Ronghou Liu ◽  
...  

1996 ◽  
Vol 59 (5) ◽  
pp. 481-486 ◽  
Author(s):  
HSING-YI HSIEH ◽  
BONITA A. GLATZ

Propionicin PLG-1, a bacteriocin produced by Propionibacterium thoenii strain P127, was tested for characteristics that could determine its usefulness as a food preservative: long-term storage stability and effectiveness in a food model system. Partially purified propionicin PLG-1 samples, lyophilized and nonlyophilized, were stored at 25, 4, and −20°C. Bacteriocin activity increased by as much as 200% over the first 10 days of storage in nonlyophilized samples stored at 25 or 4°C. Activity then decreased gradually for samples stored at 25°C while samples stored at 4°C retained high activity through 14 weeks of storage. Nonlyophilized samples frozen at −20°C and lyophilized samples stored at all temperatures did not change significantly in activity through 25 weeks of storage. Propionicin was added at 100 and 1,000 arbitrary units (AU)/ml to lactobacilli MRS broth and to skim milk, each inoculated with 105 cells per ml of Lactobacillus delbrueckii ATCC 4797. Upon incubation at 37°C with 1,000 AU/ml, cell numbers were reduced by at least 4 log units within 2 h and no viable cells were detected after 96 h in either medium. With 100 AU/ml of propionicin, viable cells were reduced by 2 log units within 12 h at 37°C, but culture growth resumed after 24 h. At 15°C, no viable cells were detected after 48 h in the presence of 1,000 AU/ml of propionicin, while viable cell counts were gradually reduced to about 10 cells per ml by 168 h in the presence of 100 AU/ml of propionicin.


2007 ◽  
Vol 280-283 ◽  
pp. 743-746 ◽  
Author(s):  
Chun Lei Dai ◽  
Jin Long Yang ◽  
Yong Huang

In the industrialization of gelcasting, storage of ceramic slurry has been one of the key problems that must be solved. Except for sedimentation of ceramics particle, solidification properties of slurries were also affected after long-term storage. In this article, some factors in the process of slurry were discussed, and corresponding solution methods were put forward.


Sign in / Sign up

Export Citation Format

Share Document