Search results for " specification" in Articles / App Notes
Article
Essentials in Quality Risk Management
…file (QTTP), through CQA generation to analytical method selection, unit operation characterization, specification and acceptance criteria limit generation, critical process parameters and control se…
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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…
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Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
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Boosting biopharma resilience: The need to shift focus and increase collaboration
Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength an…
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Top challenges in recombinant protein purification process development
In this video, Emma Lind, Product Manager for Chromatography Resins at Cytiva answers questions from BioPharm International about the challenges faced by process developers working with recombi…
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As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
Development beyond traditional monoclonal antibodies (mAbs) is increasing, and today, we see antibody variants like multispecific and bispecific antibodies and antibody fragments. In mAb proc…
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Trace metals getting you down? Learn what’s really in your cell culture media
Heavy metal might have a place in your music playlist, but heavy metals should stay out of your cell culture media. Heavy metal impurities in your media can have a drastic effect on cell vi…
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Future-proof your AAV process with a complete producer cell line – just induce and grow
Stable producer cell lines helped to make mAb therapies the powerhouses they are today. To deliver on the promise of AAV-based gene therapy for prevalent diseases, we need similar technology. …
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Chromatography for the Diversified Antibody Pipeline
CytivaVideo
In this video, Eva Heldin, Section Manager of Antibody Application in R&D at Cytiva is interviewed by BioPharm International and shares what antibody therapies are in the pipelin…