Search results for " report" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
A more comprehensive practical guidance, Technical Report 57, published by the Parenteral Drug Association (PDA) and specific for biopharmaceuticals, provides the best practical guidance currently ava…
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Design of Experiments for Analytical Method Development and Validation
The outcome of the risk assessment is a small set (3 to 8) of risk-ranked factors that may influence the reportable result of the assay. There are many kinds of factors, so factor identification and h…
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The Affordable Care Act's Impact on Innovation in Biopharma
• Consider alternative clinical data sources in addition to RCTs such as post-market longitudinal studies, patient reported outcomes, and other sources of real world evidence.
• Generate evidenc…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
“For LV vectors, titer losses of 30–50% during sterile filtration have been reported in several publications, often due to excessive aggregation and vector loss. Through our filter screening efforts, …
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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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Top challenges in recombinant protein purification process development
So in addition to that, as I would feel would be a major challenge in process development, maybe you can highlight some other challenges that are being reported by scientists?
Emma Lind: Absolutel…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
For medicines that come directly from manufacturers, you can already see the serial numbers on some products,” he reports.
COVID-19 vaccines, approved under emergency use authorization, were not r…
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Setting Up Bioprocessing Systems for Digital Transformation
Unplausible results in downstream reports can easily be validated and verified using digital representatives with no further experimental effort. Such models can further be used for analyzing root cau…
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Effectively Managing Data in Process Development
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Traditional methods for capturing, storing, querying, and managing process development data are time-consuming, prone to error, and can hinder collaboration. Gain a deepe…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Two examples are the International Site for Pharmaceutical Engineers and the Parenteral Drug Association, which have a lot of different guidelines or technical reports that are developed by groups of …