Search results for " production" in Articles / App Notes
Article
Biopharma Seeks Balance
FDA’s expedited approval process moves drugs to market faster, requiring developers to shorten the path from lab scale to production scale.
Moving from one technology process during scale up to…
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
Over the last two decades, there has been a major consolidation of the industry players, with several national fractionators becoming either commercial entities or ceasing production. The consequence …
Article
Leveraging Data for Better Biopharmaceutical Process Control
Some companies still have a disconnect between production experts and those who work on statistics and data analysis. This approach does not facilitate data-driven thinking.
As I found while …
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Last year also marked a significant step towards integrating continuous manufacturing into pharmaceutical production for a small-molecule drug when FDA approved, for the first time, a manufacturer’s c…
Article
Managing Risk in Raw Material Sourcing
…P capacities in its facilities, including its site in Panoli, India, which, Ohri says, is ramping up production of J.T.Baker high-purity low endotoxin (HPLE) sugars, as well as multi-compendial cGMP …
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Advancing Single-Use Technology Through Collaboration
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There is a big difference, however, between using a disposable component here and there and using a large-scale, fully single-use system for the entire commercial production process, such as the…
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
Biopharma in 2015: A Year for Approvals and Innovations
…ess 5 g/L Titers of Monoclonal Antibodies
Trends in Single-use Bioreactors
Process economy and production capacity using single-use versus stainless steel fermentation equipment
A Bright Fut…
Article
Technologies and Practices Must Evolve to Meet Demand
Jan 01, 2015 By Rita Peters
Through Dec. 3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule …
Article
Single-Domain Antibodies for Brain Targeting
Smaller recombinant antibody fragments as single-domain antibodies (sdAbs) are emerging as credible alternatives because of their target specificity, high affinity, and cost-effective recombinant prod…