Schenck, Luke Patel, Paresma Sood, Ramesh Bonaga, Llorente Capella, Peter Dirat, Olivier Erdemir, Deniz Ferguson, Steven Gazziola, Cinzia Gorka, Lindsey Saunders
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Published in
Journal of Pharmaceutical Sciences
These proceedings contain presentation summaries and discussion highlights from the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Workshop on Co-processed API, held on July 13 and 14, 2022. This workshop examined recent advances in the use of co-processed active pharmaceutical ingredients as a technology...
Ahuja, Rahul Srichandan, Sudeepa Meena, Jairam Biswal, Bichitra Kumar Panda, Amulya K
Published in
Journal of pharmaceutical sciences
Receptor binding domain (RBD) of SARS-CoV-2 is a prime vaccine target against which neutralizing antibody responses are directed. Purified RBD as a vaccine candidate warrants administration of multiple doses along with adjuvants and use of delivery systems to improve its immunogenicity. The present investigation examines the immunogenicity of RBD d...
Kawaguchi, Maho Noda, Marin Ono, Akari Kamiya, Mariko Matsumoto, Makoto Tsurumaru, Masako Mizukami, Shusaku Mukai, Hidefumi Kawakami, Shigeru
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Journal of pharmaceutical sciences
Delivery of messenger RNA (mRNA) using lipid nanoparticles (LNPs) is expected to be applied to various diseases following the successful clinical use of the mRNA COVID-19 vaccines. This study aimed to evaluate the effect of the cholesterol molar percentage of mRNA-LNPs on protein expression in hepatocellular carcinoma-derived cells and in the liver...
Patel, Himakshi K Zhang, Kun Utegg, Rachael Stephens, Elaine Salem, Shauna Welch, Heidi Grobe, Svenja Schlereth, Julia Kuhn, Andreas N Ryczek, Jeff
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Published in
Journal of pharmaceutical sciences
mRNA vaccines have been established as a safe and effective modality, thanks in large part to the expedited development and approval of COVID-19 vaccines. In addition to the active, full-length mRNA transcript, mRNA fragment species can be present as a byproduct of the cell-free transcription manufacturing process or due to mRNA hydrolysis. In the ...
Ibrahim, Mariam Wallace, Ian Ghazvini, Saba Manetz, Scott Cordoba-Rodriguez, Ruth Patel, Sajal M
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Journal of pharmaceutical sciences
Pulmonary delivery is the main route of administration for treatment of local lung diseases. Recently, the interest in delivery of proteins through the pulmonary route for treatment of lung diseases has significantly increased, especially after Covid-19 pandemic. The development of an inhalable protein combines the challenges of inhaled as well as ...
Kale, Akanksha Gaur, Amitabh Menon, Ipshita Chirmule, Narendra Bagwe, Priyal Jawa, Rayan Vijayanand, Sharon Patil, Smital Suresh, Surekha Jawa, Vibha
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Published in
Journal of pharmaceutical sciences
Vaccines against SARS-CoV-2 have transformed the course of the COVID-19 pandemic with more than 30 authorizations. More than 2 billion people have been vaccinated with these vaccines developed on very different manufacturing platforms. We have reviewed the unprecedented work done in various aspects of the authorized vaccines and listed three potent...
Hickey, John M Jacob, Shaleem I Tait, Andrew S Vahid, Fatemeh Dastjerdi Barritt, Joseph Rouse, Sarah Douglas, Alexander Joshi, Sangeeta B Volkin, David B Bracewell, Daniel G
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Journal of pharmaceutical sciences
Adenovirus vectors have become an important class of vaccines with the recent approval of Ebola and COVID-19 products. In-process quality attribute data collected during Adenovirus vector manufacturing has focused on particle concentration and infectivity ratios (based on viral genome: cell-based infectivity), and data suggest only a fraction of vi...
Salem, Heba F Moubarak, Ghada Abdelsabour Ali, Adel A Salama, Abeer A A Salama, Alaa H
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Journal of pharmaceutical sciences
Budesonide (BUD), a glucocorticoids drug, inhibits all steps in the inflammatory response. It can reduce and treat inflammation and other symptoms associated with acute lung injury such as COVID-19. Loading BUD into bilosomes could boost its therapeutic activity, and lessen its frequent administration and side effects. Different bilosomal formulati...
Tuesuwan, Bodin Mueannoom, Wunlapa Jamnongtanachot, Promporn Khunvichai, Ariya Pavitrapok, Chiravi Wongpakdee, Kawinthida Sra-Ium, Supasil Mahanonda, Nithi Vongsutilers, Vorasit
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Journal of pharmaceutical sciences
The COVID-19 pandemic outbreak has been overwhelming the healthcare system worldwide. A rapidly growing number of younger pediatric patients in Thailand necessitated the formulation of favipiravir, the most locally accessible antiviral agent against COVID-19, into a child-friendly dosage form as a safer alternative to a dispersion of crushed tablet...
Oude Blenke, Erik Örnskov, Eivor Schöneich, Christian Nilsson, Gunilla A Volkin, David B Mastrobattista, Enrico Almarsson, Örn Crommelin, Daan J A
Published in
Journal of pharmaceutical sciences
The remarkable impact of mRNA vaccines on mitigating disease and improving public health has been amply demonstrated during the COVID-19 pandemic. Many new mRNA-based vaccine and therapeutic candidates are in development, yet the current reality of their stability limitations requires their frozen storage. Numerous challenges remain to improve form...