Search results for " EMA" in Articles / App Notes
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
This led to discussions with other regulatory bodies as well, such as EMA and PMDA. An essential part of the discussions with the regulatory agencies was process understanding and at that time, we had…