Search results for "biologic"
Article
Platform Technologies Improve Protein Expression
…st in platform technologies for protein expression that will not only facilitate the development of biologic drug candidates, but also increase yield and speed to market.
A platform of benefi…
Article
Process Chromatography Selection for Downstream Processing Applications
Some factors companies may consider when selecting a separation technology include the stability of the biologic, buffer compatibility, and ease of scale-up. In this roundtable discussion, industry ex…
Article
Analysis of Glycosylation in Biosimilars
…uence is the same, the glycosylation pattern may be different, potentially altering the protein’s biological properties. It is, therefore, important to use a cell line that produces an appropriate gl…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In addition, the authors wish to recognize and thank Lonza Biologics (Slough, UK) for the licensing of and permission to modify the GS-CHO expression system.
References
1. J.M. Reichert, MAbs. 7…
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…
Article
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…