Search results for " report"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The data used in the impact assessment may come from structure-activity relationship (SAR) studies, nonclinical studies, clinical exposure history, and toxicology reports (4). For platform molecules, …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The ratios of gene levels between day 9 and day 11 for each treatment were reported. The gene functions were obtained from the website of the National Center for Biotechnology Information (www.ncbi.nl…
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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…
Article
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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To provide required reporting on CME/CE activity to the appropriate monitoring bodies and involved CME/CE providers;
T…
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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…
Article
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…