Application of a Statistical Approach to Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 1: Identification of Critical Process Parameters for Impurities

2022 ◽  
Author(s):  
Yasunori Abe ◽  
Kosuke Emori
Keyword(s):  
Process Parameters ◽  
Quality By Design ◽  
Statistical Approach ◽  
Process Development ◽  
Design Principles ◽  
Critical Process Parameters ◽  
Critical Process

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 ◽  
...  
Keyword(s):  
Process Parameters ◽  
Measles Virus ◽  
Process Development ◽  
Process Conditions ◽  
Forced Degradation ◽  
Forced Degradation Studies ◽  
Critical Process Parameters ◽  
Degradation Studies ◽  
High Concentrations ◽  
Critical Process

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.

scholarly journals Designing ultra-small nanostructured lipid carriers: critical process parameters

2020 ◽  
Author(s):  
Maria Mendes ◽  
João Basso ◽  
João Sousa ◽  
Alberto Pais ◽  
Carla Vitorino
Keyword(s):  
Process Parameters ◽  
Nanostructured Lipid Carriers ◽  
Critical Process Parameters ◽  
Critical Process

scholarly journals Application of Statistical Design to Assess the Critical Process Parameters of Ethanol Injection Method for the Preparation of Liposomes

2019 ◽  
Vol 18 (1) ◽  
pp. 103-111 ◽  
Author(s):  
Sayani Bhattacharyya ◽  
Bharani S Sogali
Keyword(s):  
Particle Size ◽  
Process Parameters ◽  
Particle Size Analysis ◽  
Polydispersity Index ◽  
Size Analysis ◽  
Ethanol Injection ◽  
Injection Method ◽  
Critical Process Parameters ◽  
Critical Process ◽  
Ethanol Injection Method

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)

scholarly journals Aeration and Shear Stress Are Critical Process Parameters for the Production of Oncolytic Measles Virus

2019 ◽  
Vol 7 ◽  
Author(s):  
Tanja A. Grein ◽  
Daniel Loewe ◽  
Hauke Dieken ◽  
Tobias Weidner ◽  
Denise Salzig ◽  
...  
Keyword(s):  
Shear Stress ◽  
Process Parameters ◽  
Measles Virus ◽  
Critical Process Parameters ◽  
Critical Process
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