Search results for " methods"
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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…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
The QTPP should not be confused with the drug product specification, which created later, is generally a list of specific test methods to perform and their acceptance criteria designed to ensure drug …
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Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
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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…
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Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
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Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
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Sodium hydroxide (NaOH) cleaning-in-place is the widely accepted method of sanitization employed by biopharmaceutical manufacturers to avoid the excessive costs and delays of a…
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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.
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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
Another manufacturing challenge in viral vector production, Murphy points out, is the development and qualification of robust analytical methods to measure product quality.
“At the present time…