Search results for " biologic" in Articles / App Notes
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Giner-Casares
Cell culture is widely employed in biomedical applications and has numerous applications, spanning from diagnosis, therapy, and the production of biological drugs. Cells used for bio…
Article
Framing Biopharma Success in 2016
If the introduction of generic alternatives is a sign of maturity in the biologic-based drug segment, the biopharma companies may want to examine lessons learned by small-molecule based pharma compani…
Article
GMP Challenges for Advanced Therapy Medicinal Products
In particular, they often do not have adequate systems in place for evaluating the quality of starting and raw materials, which is a vital necessity in the production of advanced, usually biological, …
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
FDA’s focus on the need for updates is creating both opportunities and challenges for biologics manufacturers involved in the scale-up and transfer of production technologies. Single-use and modular t…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
While in-vitro and/or in-vivo biological activity assessments provide vital holistic information on biosimilarity, a combination of ligand- and Fc-binding assessments may provide more sensitive and me…
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Biopharma Manufacturers Respond to Ebola Crisis
A main strategy is to explore whether drugs developed as countermeasures to influenza pandemics and other biological threats could be effective against Ebola. Biomedical development programs at the Na…
Article
Challenges of Protein Aggregation During Purification
32-35
Removal of protein aggregates from biologic APIs is crucial due to their potential to increase immunogenicity. While most aggregates are formed during upstream operations, and the risk for …
Article
Q&A with Industry Leaders: Rita Peters
…h educational sessions and new product introductions revealed a recurring theme: a stronger focus on biologic drug research and development versus small-molecule development.
At Pittcon 2014, the…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22:1383–91.
10. United States Pharmacopeia: USP/NF General Chapter 125. United …
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Advancing QbD in the EU
The biggest change in the GMP guide is a massive extension of Annex 2 on the manufacture of biological active substances, which has been extended from five to 32 pages and from 43 sub-items to 70.
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