Search results for " identity" in Articles / App Notes

Article Ensuring the Quality of Biologicals
recognizes that monographs provide public standards for the quality of medicinal products and their constituents, the monographs are not sufficient to assess identity and similarity of medicinal produ…

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article Continuous Manufacturing: A Changing Processing Paradigm
Sinclair says the issue of batch identity is up to the user to define prior to manufacture and that “the real regulatory issue is one of traceability when there is a problem that has consequences of a…

Article Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…

Article Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe. Feb 01, 2015 By Sean Milmo BioPharm International The European Medicines Agency (EMA) has r…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

Article Setting Standards for Biotech Therapeutics in India
The certificate of analysis should be submitted and should include the critical quality attributes with respect to identity, content, and potency of the product. Stability of the material should be al…

Article Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve. The European Union is strengthening its pioneering role in the regulati…

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. A…

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time. ABSTRACT Monoclonal antibodies represent a significant portion of sales in the biopharma…

Show All Results

Previous PageNext Page