Search results for " therapeutic"
Article
Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
Article
FDA Approves First Biosimilar
To date, there are a total of five 351(k) applications that are publicly disclosed, including the one for Zarxio, said Leah Christl, associate director for therapeutic biologics and biosimilars in the…
Article
The Bullish Outlook for Biosimilars
Taking this approach will raise the bar on what it takes to be “market similar” by forcing new entrants to demonstrate how their product adds value through both its therapeutic and service characteris…
Article
What Drove Biopharma Development in 2014?
In addition to developing quality biopharmaceuticals, manufacturers continue to create innovative medicines for treating various diseases, thus driving the trend of next-generation antibody-based ther…
Article
Biopharma Manufacturers Respond to Ebola Crisis
And Sarepta Therapeutics (Cambridge, MA) is looking to produce clinical supplies of its oligonucleotide (AVI 7537) for initial studies.
A promising treatment is favipiravir (T-705), an oral tablet…
Article
Challenges and Trends in Biopharma Facility Design
…uld become cloneable facility platforms or enter into new production needs, for example for the cell therapeutic and personalized medicine market.
Kranjac (Cytiva): Beyond monoclonal antibodies, …
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Fourth is the extension of the QbD concepts from the traditional process development to analytical development and other key activities associated with the commercialization of biotech therapeutics.
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Article
Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Sep 1, 2014
By: Jane Wan
BioPharm International
Volume 27, Issue 9, pp. 8-12
On March 25, 2014, the…
Article
Challenges of Protein Aggregation During Purification
…nces in the affinities, charges, sizes, hydrophobicities, and other physiochemical properties of the therapeutic molecule and impurities, including aggregates. Different combinations of unit operatio…
Article
Applying GMPs to the BioPharma Supply Chain
Patient-centered organization culture
Suppliers need to appreciate the intended use of the medicinal and therapeutic products that their raw materials have been used to produce. They need to under…