Search results for " process"
Article
Maximize resin usage with continuous bioprocessing
Periodic counter-current chromatography (PCC) is a multi-step approach to maximize the chromatography resin capacity utilization and minimize process time. The technology employs three or more chromat…
Article
Vaccine Development Faces Urgency and Challenges
Scientific advances
To achieve these goals, scientists in academia, government, and industry are moving to tap new genomics technology to reduce the long R&D process and help modernize vaccine dev…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
This development will lead to the increasing availability of high quality single-use material information which, in turn, will provide greater technical insight to process performance. This will help …
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Innovative Therapies Require Modern Manufacturing Systems
At the same time, though, the development of such innovative and targeted therapies heightens the importance of establishing production systems and processes capable of fast scale-up of high-quality c…
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Framing Biopharma Success in 2016
… now prescribed as lower-cost generic drugs--has implications for drug development and manufacturing processes.
A market research study estimates that the global biosimilars/follow-on-biologics m…
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Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The staggered parallel multi-step configuration of the system allows unattended processing of eight samples in less than 24 hours. The system was validated with a random panel of 45 whole-cell culture…
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Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…
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New Era for Generic Drugs
An unanticipated problem is that more than 1400 applications were filed this past year, many more than projected, making it even more necessary for OGD to implement a new review process that sets prio…
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DoE Provides Benefits, but Preparation Is Necessary
“DoE study design and data processing requires an understanding of statistics theory and models, which can be challenging for many new users,” he comments.
Obtaining relevant data
In most DoE …
Article
EMA Collaborates with HTA Assessment Networks
“This is not necessarily linked to the development of new manufacturing processes per se, but more to the need of identifying a common set of data requirements,” he added.
EUnetHTA has been step…