Search results for " potency" in Articles / App Notes

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Ensuring the Quality of Biologicals
May 02, 2015 By Stephen Wicks, PhD Pharmaceutical Technology Volume 39, Issue 5 The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …

Article Ligand-Binding Assays and the Determination of Biosimilarity
In addition, ligand-binding assays enable the characterization of the potency of different biosimilars and provide crucial information on the affinity (dissociation rate constant, KD) and selectivity …

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 Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Aug 2, 2014 By: Cynthia Challener, PhD Pharmaceutical Technology Volume 37, Iss…

Article Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
“For structurally more simple biological medicinal products, a comparative clinical efficacy study may not be necessary if similarity of physicochemical characteristics and biological activity or pote…

Article Elucidating Biosimilars Characterization
Comparison of analytical data forms the case for proving whether two molecules are structurally similar or not; however, data from cell-based potency and bioequivalence assays will also be required. U…

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…

Article Regulatory Challenges in the QbD Paradigm
… to demonstrate that the change has no adverse effect on the identity, strength, quality, purity, or potency of the product. Reporting of the change must be in accordance with regulation or guidance …

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition, if an in vivo animal potency model is available, the results don't usually predict the human response to the product with regards to the protein structure-immunogenecity/antigencity relat…

Show All Results

Previous Page