Challenges and Considerations in Development and Manufacturing of High Concentration Biologics Drug Products
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Pharmaceutical Innovation"
DOI: 10.1007/s12247-019-09414-3
Abstract: With the advent of novel biotherapeutics in indications such as oncology, the attention has moved to making these therapies patient centric, potentially available for self-administration. Given the volume limitations of the other convenient routes of… read more here.
Keywords: development manufacturing; concentration; drug products; high concentration ... See more keywords
Enabling development, manufacturing, and regulatory approval of biotherapeutics through advances in mass spectrometry.
Sign Up to like & getrecommendations! Published in 2021 at "Current opinion in biotechnology"
DOI: 10.1016/j.copbio.2021.08.001
Abstract: Rapid technological advances have significantly improved the capability, versatility, and robustness of mass spectrometers which has led to them playing a central role in the development, characterization, and regulatory filings of biopharmaceuticals. Their application spans… read more here.
Keywords: enabling development; product; manufacturing regulatory; development manufacturing ... See more keywords
Development of a manufacturing process for the drug fenleuton
Sign Up to like & getrecommendations! Published in 2017 at "Tetrahedron Letters"
DOI: 10.1016/j.tetlet.2016.11.094
Abstract: Abstract A new strategy for a large scale synthesis is developed and evaluated by the improvement of the current synthesis for fenleuton, a drug with important applications in leukotriene-mediated inflammatory diseases that acts through inhibition… read more here.
Keywords: process drug; manufacturing process; drug; development manufacturing ... See more keywords
Development of a Manufacturing Process toward the Convergent Synthesis of the COVID-19 Antiviral Ensitrelvir
Sign Up to like & getrecommendations! Published in 2023 at "ACS Central Science"
DOI: 10.1021/acscentsci.2c01203
Abstract: We describe the development of the practical manufacturing of Ensitrelvir, which was discovered as a SARS-CoV-2 antiviral candidate. Scalable synthetic methods of indazole, 1,2,4-triazole and 1,3,5-triazinone structures were established, and convergent couplings of these fragments… read more here.
Keywords: manufacturing process; development; development manufacturing; ensitrelvir ... See more keywords
Environmental regulations, capacity utilization, and high-quality development of manufacturing: an analysis based on Chinese provincial panel data
Sign Up to like & getrecommendations! Published in 2021 at "Scientific Reports"
DOI: 10.1038/s41598-021-98787-y
Abstract: The high-quality development of the manufacturing industry is an important strategic task for Chinese economic development. The rapid development of the manufacturing industry is also accompanied by problems such as overcapacity and environmental pollution. This… read more here.
Keywords: capacity utilization; high quality; development manufacturing; quality development ... See more keywords