Search results for "analysis"
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…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…