Search results for " method" in Articles / App Notes
Article
Manufacturers Struggle with Breakthrough Drug Development
The plan should consider how estimated market demand would relate to manufacturing facilities, lifecycle process, methods validation, and stability studies. Early submission of CMC information will al…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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Moving Biosimilars Forward in a Hesitant Market
“Say [a company has] taken up an innovative method to produce a biosimilar, then that method also has to be validated. That validation data also has to be given to FDA, and that requires more time and…
Article
Top challenges in recombinant protein purification process development
So I'm really looking forward to talking more about some methods that can be used to help navigate this complex field, as well as address some of these concerns that are being raised by scientists. I'…
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Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
Article
Using Digital Twins to Model Process Chromatography
By explicitly describing all components within a process, from raw material to method, one can account for any changes.
To predict the impact on process performance, a profound understanding of th…
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Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
The final version of our method with resin and chemically dependent hold times is highly efficient as an integral part of the packing procedure.
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Effectively Managing Data in Process Development
Gain a deeper understanding of the shortcomings of today’s methods and the factors you need to consider when adopting a solution to successfully overcome them.
Article
ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The International Society for Pharmaceutical Engin…
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Gene Therapies Push Viral Vector Production
The current AAV manufacturing process using the HEK-293 cell line can only be increased by a “scale-out” method, notes Touw. This is carried out by implementing more hyperstacks, or cell stacks, for p…