scholarly journals Forced Degradation Studies to Identify Critical Process Parameters for the Purification of Infectious Measles Virus

Viruses ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 725 ◽  
Author(s):  
Loewe ◽  
Häussler ◽  
Grein ◽  
Dieken ◽  
Weidner ◽  
...  

Oncolytic measles virus (MV) is a promising treatment for cancer but titers of up to 1011 infectious particles per dose are needed for therapeutic efficacy, which requires an efficient, robust, and scalable production process. MV is highly sensitive to process conditions, and a substantial fraction of the virus is lost during current purification processes. We therefore conducted forced degradation studies under thermal, pH, chemical, and mechanical stress to determine critical process parameters. We found that MV remained stable following up to five freeze–thaw cycles, but was inactivated during short-term incubation (< 2 h) at temperatures exceeding 35 °C. The infectivity of MV declined at pH < 7, but was not influenced by different buffer systems or the ionic strength/osmolality, except high concentrations of CaCl2 and MgSO4. We observed low shear sensitivity (dependent on the flow rate) caused by the use of a peristaltic pump. For tangential flow filtration, the highest recovery of MV was at a shear rate of ~5700 s−1. Our results confirm that the application of forced degradation studies is important to identify critical process parameters for MV purification. This will be helpful during the early stages of process development, ensuring the recovery of high titers of active MV particles after purification.

Author(s):  
Tanja A. Grein ◽  
Daniel Loewe ◽  
Hauke Dieken ◽  
Tobias Weidner ◽  
Denise Salzig ◽  
...  

2020 ◽  
Author(s):  
Maria Mendes ◽  
João Basso ◽  
João Sousa ◽  
Alberto Pais ◽  
Carla Vitorino

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Dimal A. Shah ◽  
Ishita I. Gondalia ◽  
Vandana B. Patel ◽  
Ashok Mahajan ◽  
Usmangani Chhalotiya ◽  
...  

Abstract Background A sensitive, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the analysis of Remogliflozin etabonate in tablet formulation. HPTLC plates precoated with silica gel 60 F254 were used as the stationary phase; methanol: ethyl acetate: toluene: NH3 (2:4:4:0.1, v/v/v) was used as mobile phase, and densitometry was used for the quantitative estimation of the drug. The proposed method was validated with respect to linearity, accuracy, precision, and robustness and applied for the estimation of drug in tablet dosage form. Results The Rf value of Remogliflozin etabonate was observed to be 0.61. The densitometric estimation was performed in reflectance mode at 229 nm. The method was found to be linear in the range of 500–8000 ng/band for Remogliflozin etabonate. The possible degradation pathway was estimated by performing forced degradation studies. The degradant peaks were well resolved from the drug peak with acceptable resolution in their Rf value. Conclusion An accurate and precise high-performance thin-layer chromatographic method has been developed for the quantification of Remogliflozin etabonate in tablets. Forced degradation studies were performed, and drug was found to be highly susceptible to acid, base hydrolysis, and oxidative stress degradation and gets converted into active drug Remogliflozin. Both Remogliflozin etabonate and Remogliflozin bands were well resolved. The method was applied for the analysis of drug in tablet formulation, and it can be used for routine quality control analysis, as well as for the analysis of stability samples.


2021 ◽  
Author(s):  
Abderrazaq Hamdache ◽  
Lamia Grib ◽  
Celia Grib ◽  
Lydia Adour ◽  
Hakim Zatout ◽  
...  

2019 ◽  
Vol 18 (1) ◽  
pp. 103-111 ◽  
Author(s):  
Sayani Bhattacharyya ◽  
Bharani S Sogali

In the present study custom screening design was employed to observe the effect of four critical process parameters on particle size and polydispersity index of the liposomal formulation made by ethanol injection method. The four process parameters selected were lipid ratio, rate of injection, phase volume ratio and rotational speed of magnetic stirring. Eight different liposomal formulations were prepared using the design. The formulations were subjected to particle size analysis. The analysis was done at a significance level p<0.05 and found that the process parameters had significant effect on the particle size and polydispersity index of the formulations. The design was optimized for the individual responses with an overall desirability of more than 50%. Three batches of liposomes were formulated at optimized process parameters which matched the target as predicted by the design. Therefore, it can be concluded that the design was effective in production of nano sized stable monodisperse liposomes by ethanol injection method. Dhaka Univ. J. Pharm. Sci. 18(1): 103-111, 2019 (June)


2017 ◽  
Vol 9 (5) ◽  
pp. 121 ◽  
Author(s):  
Hemant K. Jain ◽  
Archana A. Gunjal

Objective: To develop an accurate, simple, precise and specific stability indicating RP-HPLC method for estimation of dimethyl fumarate in bulk and capsules.Methods: An Inertsil ODS (150x4.6 mm, 5µ) column and a mobile phase containing acetonitrile: potassium dihydrogen phosphate buffer pH 6.8 (50:50% v/v) was used for this study. The flow rate was maintained at 1.0 ml/min; column temperature was fixed at 35 °C and UV detection was carried out at 210 nm. The forced degradation studies were performed and method was validated with as per ICH guidelines.Results: The retention time of dimethyl fumarate was found to be 3.3±0.02 min. The value of correlation coefficient between peak area and concentration was found to be 0.9993. The mean percent recovery of dimethyl fumarate in capsules was found in the range of 99.65 to 101.64%. The results of forced degradation studies indicated that the drug was found to be stable in basic, oxidative and thermal conditions while degraded in acidic conditions.Conclusion: It can be conducted from results that the developed HPLC method is simple, accurate, precise and specific. Results of stress testing study revealed that the method is stability indicating. Thus, this method can be used for routine analysis of dimethyl fumarate capsules and check their stability.  


Sign in / Sign up

Export Citation Format

Share Document