Search results for " process" in Articles / App Notes
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
…rs or flaws in one or more of the following, non-discrete categories of the research and publication process: biological reagents and reference materials, study design, laboratory protocols, and data…
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Ensuring the Quality of Biologicals
The elaboration of biological monographs is a tiered process starting with the originator product, but the monograph may be subsequently adapted to account for biosimilar products. For complex biologi…
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Drug Discovery and Development in India
“There is a need for speeding the regulatory processes at all stages of drug development starting from seeking licenses for initiating drug discovery, conducting clinical trials in India to obtaining …
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FDA Approves First Biosimilar
Legal issues linger
Amgen has alleged that Sandoz purposely did not share with Amgen its 351(k) biologics license application (BLA) for filgrastim, its manufacturing processes, and dossier for the…
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Ligand-Binding Assays and the Determination of Biosimilarity
Therefore, matching the binding activities of a biosimilar candidate to those of the reference product is part of the process of developing a biosimilar and something that is expected by both the Euro…
Article
What Drove Biopharma Development in 2014?
In 2014, there was significant increased interest in continuous processing, both upstream and downstream. On the PDF site, this trend was evident based on webinar invitations, as well as in published …
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Biopharma Manufacturers Respond to Ebola Crisis
DOD research agencies have supported development of this process for “infecting” tobacco plants with an anti-viral protein that then can be extracted and processed into a purified serum. There has bee…
Article
Single-Domain Antibodies for Brain Targeting
The transport of FC5 and FC44 across the human brain endothelial cells is polarized, charge-independent, and temperature-dependent, suggesting a receptor-mediated process.
Abulrob et al. demonstra…
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Gowning Practices Provide Clues to cGMP Compliance
This can be contrasted with decentralized zones that require material and personnel to enter and exit production areas multiple times in the course of processing a single batch. Operational time is wa…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Smith also notes that the adoption of single-use manufacturing technology accelerates process validation and analytical testing for Novavax’s vaccines and may allow for ultimate regulatory approval of…