Search results for " development" in Articles / App Notes
Article
Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?
The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
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Article
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
5:10 - Top tips for implementing mechanistic modeling into process development work.
6:50 - Key benefits of in silico process development driven by mechanistic models.
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Article
Setting Up Bioprocessing Systems for Digital Transformation
Thus, deviations can be better investigated, and processes may be developed to be more efficient and robust, with intensified process development, when transformed into the digital space.
“AI in i…
Article
Good Manufacturing Practices: Challenges with Compliance
…ce-president of manufacturing operations at Emergent BioSolutions, regarding the challenges contract development and manufacturing organizations (CDMOs) face when adhering to current good manufacturi…
Article
Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
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Understanding Validation and Technical Transfer, Part 2
The quality assurance department must be involved at all phases of protocol development and must approve the final protocol before validation begins.
Protocols fit two broad categories. Qualifi…
Article
Biosimilars to Drive Modern Manufacturing Approaches
…ar applications as of the end of July 2016, and the agency is assisting with more than 60 biosimilar development programs.
These efforts will be supported by a new agreement on policies for renew…
Article
Modeling Bioreactor Performance
Why model bioreactor performance?
There are many reasons why biopharmaceutical manufacturers invest in the development of bioreactor modeling capabilities. Modeling is used to gain insight into no…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Background
The development of serum-free mammalian cell-culture media technology has been impressive during the past few decades. The advances can perhaps best be appreciated when compared directl…
Article
Process Chromatography Selection for Downstream Processing Applications
Important factors such as column design, resin development, and automation have all played a role in simplifying the purification process, in some cases reducing it from five steps to three (1). Selec…