Search results for " therapeutic"
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
… animal-component-free processes that have now become standard for producing recombinant antibodies, therapeutic proteins, and some vaccines. Although the same concerns for safety are ultimately expe…
Article
Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
By Mark Plavsic
Use of continuous cell lines in the manufacture of biological therapeutic products, such as vaccines, recombinant proteins, and monoclonal antibodies, is associated with the concom…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
…cies of the trypsinization technique and help realize the huge potential of adherent cells to enable therapeutic and diagnostic solutions.
Cell attachment requires the interaction of cell membran…
Article
mAbs to Watch in 2016
Obiltoxaximab—Elusys Therapeutics’ mAb, obiltoxaximab, which will go by the trade name Anthim, differs significantly from the rest of the mAb pack. The investigational agent for the treatment of inhal…
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Taking a “Development-by-Design” Approach to Cell Therapies
… successfully completed projects in North America, Europe, and Asia for companies that include Argos Therapeutics, Aastrom, CCRM, Humacyte, Innovacell, Janssen, kSep Systems, MolMed, Organovo, and Vi…
Article
Use of Multivariate Data Analysis in Bioprocessing
MVDA applications in cell-culture operations
Cell-culture operations are by far the most common platform used for production of protein therapeutics. In this endeavor, various advanced offline and…
Article
Fermentation for the Future
…rains that it can screen using high-throughput technology to identify the optimal choice for a given therapeutic protein. These strains do not form IBs and produce the protein in the periplasm, from …
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
In addition, continuous processing offers biotechnology companies increased flexibility—you can use the same platform for various types of therapeutic proteins. More flexible management of manufacturi…