Search results for " start" in Articles / App Notes
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
In the 50 L cultivations, the cells reattached and started to grow on the new microcarriers without lag phase. The cell growth rate was shown to be similar in both the 10 L and 50 L cultures in three …
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Likewise companies which haven’t started their clinical development can put together a clinical program that encompasses both the EU and the US, again, by incorporating an EU reference standard.”
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Article
PDA's Technical Report for Biotech Cleaning Validation
The industry needs to provide more scientific rationales and data to support that practice, and such improvements in support documentation have started to occur.
SAMPLING METHODS
Another key p…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…