Search results for "biopharmaceutical"
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Selecting the Right Viral Clearance Technology
Many methods to choose from
There are numerous methods that can be employed to achieve viral clearance during downstream biopharmaceutical processing, some that are better understood than others. …
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Use of Multivariate Data Analysis in Bioprocessing
The biopharmaceutical industry, however, has accrued greater benefits as evidenced by publications highlighting the use of MVDA tools both in upstream as well as downstream processes (9). This is in p…
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SEC in the Modern Downstream Purification Process
A recent trend in biopharmaceutical manufacturing is disposable or single-use technologies. If vaccine manufacturing becomes decentralized to locations throughout the world, as current trends imply, d…
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Fermentation for the Future
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have been widely used for the production of genetically engineered (recombinant) biopharmaceuticals. Typical examples…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
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Bureaucratic Roadblocks Threaten Biopharma Growth
This is particularly true in knowledge-intensive sectors such as biopharmaceuticals.
The good news is that some mature and emerging economies are making growing use of patent systems to facilita…
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Trends in Downstream Bioprocessing
DSP remains one of the most crucial and talked-about areas of biopharmaceutical manufacturing. Indeed, a survey conducted in late 2012 among 450 global subject matter experts and senior participants w…
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Regulatory Challenges in the QbD Paradigm
This article is part of a special section on biopharmaceutical trends.
With the dawn of the 21st century came the realization that changes must be made by both the pharmaceutical industry…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
While there is agreement on the value of process and product understanding, there is often debate within most biopharmaceutical companies on the extent of QbD investment and underlying cost implicatio…
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Using Digital Twins to Model Process Chromatography
BioPharm International spoke with Whitelock about how digital twins are used in biopharmaceutical process development, scale up, tech transfer, and manufacturing, particularly chromatographic polishin…