Search results for " protein" in Articles / App Notes
Article
Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015
By Jill Wechsler
BioPharm International
Volume 3, Issue 28
Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…
Article
FDA Approves First Biosimilar
In fact, FDA said in a briefing earlier this year that six batches of the EU-approved Neupogen used in the Zarxio clinical trials were “lower in protein content than the comparator products and do not…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
“High-throughput, kinetic assessment of target binding on cells for those targets that cannot be produced as soluble proteins remains a challenge for the industry,” she observes. Several companies are…
Article
Securing the Single-Use Supply Chain
He also notes that the experience with reducing the risk associated with the single-sourcing of critical chromatography media, such as protein A, can be translated to single-use systems. “Cytiva sough…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
However, when it comes to reverse-phase chromatography or HIC, the mathematical description of hydrophobic interactions between surface and proteins are not optimal today making it difficult to use th…
Article
Setting Standards for Biotech Therapeutics in India
Many new general chapters pertaining to topics such as therapeutic monoclonal antibodies, host cell proteins and DNA, and viral safety are in the works for the next IP edition.
As mentioned previo…
Article
Biopharma Manufacturers Respond to Ebola Crisis
DOD research agencies have supported development of this process for “infecting” tobacco plants with an anti-viral protein that then can be extracted and processed into a purified serum. There has bee…
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
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Another potential source of unacceptable incompatibilities is the use of contrasting expression systems in biosimilar proteins. Windisch pointed out that a distinction had to be made between different…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
coli host cell proteins (ECP) and endotoxin levels.
Next, a polishing step using Capto MMC ImpRes further reduced ECP and endotoxin levels at yields of > 86%.
Finally, Capto adhere ImpRes …