Search results for "analysis" in Articles / App Notes
Article
Viral Clearance Challenges in Bioprocessing
Comprehensive risk analysis is often effective for highlighting and prioritizing such evaluations to streamline costly virus testing, according to Greenhalgh.
Process representation
Another chal…
Article
DoE Provides Benefits, but Preparation Is Necessary
Nguyen remarks that using software to automate data collection and extraction of the relevant output parameters for statistical analysis is important. She also stresses that having an understanding of…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Extensive DNA and protein analysis is required to help avoid this problem, and further testing is conducted to ensure that no pathogens from the eggs are transferred to the vaccine. All of this testin…
Article
Manufacturers Struggle with Breakthrough Drug Development
The regulator understands that evaluations based on limited stability data and provisional specifications could mask safety issues and that permitting manufacturers to shift more CMC analysis and fina…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
When activities that were previously considered essential to retain in-house become options for outsourcing, the calculus moves beyond a simple short-term balance sheet analysis and instead turns to a…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Also, the biosimilar applicant using the non-EEA route would have to provide bridging data from structural and functional analysis, and possibly from pharmacokinetic and pharmacodynamic studies, to sh…
Article
Biotechnology Innovation and Growth in Israel
Industry Trend Analysis, Investment In Innovation Necessary (2010).
10. N. Elis, The Jerusalem Post (April 25, 2013).
11. J. Fox, Nature Biotechnology (June 2012).
12. “Health Ministry …
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
Article
Supplier-Change Management for Drug-Product Manufacturers
…or components
• Change in part number
• Change in product documentation (certificate of analysis, certificate of compliance, product drawing, content on the primary container label)
• Cha…
Article
Trends in Downstream Bioprocessing
BioPlan Associates, “2013 Biotechnology Industry Council Trends Analysis Study” (January 2013).
2. BioPlan Associates, 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and…