Zobrazeno 1 - 10
of 28
pro vyhledávání: '"Serguei Tchessalov"'
Autor:
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt, Shyam B. Mehta
Publikováno v:
AAPS PharmSciTech. 24
Scale-up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale-up and transfer were discussed in the first part of this paper and i
Autor:
Arnab Ganguly, Lisa Hardwick, Serguei Tchessalov, Steven L. Nail, Dan Dixon, Frank Kanka, Anthony Guidinas, T. N. Thompson, Cindy Reiter, Zakaria Yusoff, Ted Tharp, Joseph Azzarella, Prerona Sharma, Petr Kazarin, Alina Alexeenko, Michael J. Pikal
Publikováno v:
AAPS PharmSciTech. 24
Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of
Autor:
Feroz Jameel, Alina Alexeenko, Akhilesh Bhambani, Gregory Sacha, Tong Zhu, Serguei Tchessalov, Puneet Sharma, Ehab Moussa, Lavanya Iyer, Sumit Luthra, Jayasree Srinivasan, Ted Tharp, Joseph Azzarella, Petr Kazarin, Mehfouz Jalal
Publikováno v:
Principles and Practices of Lyophilization in Product Development and Manufacturing ISBN: 9783031126338
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::eecf4e3070ce1f5cd9eba7b87e51b9c9
https://doi.org/10.1007/978-3-031-12634-5_27
https://doi.org/10.1007/978-3-031-12634-5_27
Autor:
Feroz Jameel, Serguei Tchessalov
Publikováno v:
Principles and Practices of Lyophilization in Product Development and Manufacturing ISBN: 9783031126338
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5c8a5172d80ddbe3fdd9b3129eb7cfa9
https://doi.org/10.1007/978-3-031-12634-5_24
https://doi.org/10.1007/978-3-031-12634-5_24
Autor:
Feroz Jameel, Alina Alexeenko, Akhilesh Bhambani, Gregory Sacha, Tong Zhu, Serguei Tchessalov, Puneet Sharma, Ehab Moussa, Lavanya Iyer, Sumit Luthra, Jayasree Srinivasan, Ted Tharp, Joseph Azzarella, Petr Kazarin, Mehfouz Jalal
Publikováno v:
Principles and Practices of Lyophilization in Product Development and Manufacturing ISBN: 9783031126338
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8601250314de6b0ec9fe863486109e9d
https://doi.org/10.1007/978-3-031-12634-5_26
https://doi.org/10.1007/978-3-031-12634-5_26
Autor:
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt
Publikováno v:
AAPS PharmSciTech. 24
The freeze-drying process scale-up and transfer remain a complicated and non-uniform practice. We summarized inefficient and good practices in these papers and provided some practical advice. It was demonstrated that using the same process set points
Autor:
Serguei Tchessalov, Bakul Bhatnagar
Publikováno v:
Drying Technologies for Biotechnology and Pharmaceutical Applications
Autor:
Mehfouz Jalal, Gregory A. Sacha, Ehab M. Moussa, Tong Zhu, Petr Kazarin, Sumit Luthra, Puneet Sharma, Joseph Azzarella, Ted Tharp, Akhilesh Bhambhani, Jayasree M. Srinivasan, Feroz Jameel, Alina Alexeenko, Lavanya K. Iyer, Serguei Tchessalov
Publikováno v:
AAPS PharmSciTech
This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qu
Autor:
Joseph Azzarella, Ehab M. Moussa, Puneet Sharma, Lavanya K. Iyer, Ted Tharp, Mehfouz Jalal, Serguei Tchessalov, Akhilesh Bhambhani, Tong Zhu, Gregory A. Sacha, Alina Alexeenko, Feroz Jameel, Petr Kazarin, Rui Fang, Lokesh Kumar, Jayasree M. Srinivasan
Publikováno v:
AAPS PharmSciTech. 22
Autor:
Satoshi Ohtake, Bakul Bhatnagar, Luy Bernhard, Serguei Tchessalov, Matthias Plitzko, Alina Alexeenko, Israel B. Sebastião
Publikováno v:
Journal of Pharmaceutical Sciences. 108:2063-2074
In spray freeze-drying (SFD), the solution is typically dispersed into a gaseous cold environment producing frozen microparticles that are subsequently dried via sublimation. This technology can potentially manufacture bulk lyophilized drugs at highe