Search results for " knowledge" in Articles / App Notes
Article
Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
Further, if they’re to maintain expertise in bioprocessing, they need to have a fuller ‘toolbox’ of options, innovation, and knowledge at their disposal than other manufacturers who may need to build …
Article
Analysis of Glycosylation in Biosimilars
It is still not definitive--whether a N-acetylhexosamine is N-acetylglucosamine or N-acetylgalactosamine is not clear, for example--but knowledge already built up about the biosynthetic pathway can be…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Maintain solid knowledge of raw materials origin, sourcing, manufacturing, testing, storage, and traceability.
• Review of critical raw material specifications for adequacy and viral saf…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
Article
Antibody Purification Handbook
Access the Knowledge Center and download the Handbook.
Article
GMP Challenges for Advanced Therapy Medicinal Products
“[Our own data] has consistently shown that GMP manufacturing knowledge remains a barrier for academic triallists aiming to perform the full cycle from preclinical investigations to early and subseque…
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Implications of Cell Culture Conditions on Protein Glycosylation
Using the peaks (masses) of the spectrometric analysis, in combination with the knowledge of the N-glycan, the core structure, and the biosynthetic pathways that are present, it is possible to arrive …
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Selecting the Right Viral Clearance Technology
He hopes that companies will continue to be forthcoming with their viral clearance knowledge and experiences as a means to demonstrate to the agencies and to the public the industry’s commitment to pa…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
In conjunction with effective policies and expanded use of standards and best practices for cell culturing and authentication, knowledge of why and how often to perform cell authentication will improv…