Search results for " Biopharm"
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Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Antibody Production in Microbial Hosts
Rathore, Jyoti Batra
The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs) and related products that are capable of treating…
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Going Small to Achieve Success on the Commercial Scale
Scale-down models are used in the development of nearly every unit operation in the overall biopharmaceutical manufacturing process, including both upstream and downstream steps, and separation and fi…
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Tools for Continuous Bioprocessing Development
Would this structure be desirable for biopharmaceutical manufacturing? Although their respective regulatory environments are radically different, the two industries share some common elements: use of …
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Biopharma in 2015: A Year for Approvals and Innovations
Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of biopharmaceuticals in the industry pipeline.1
Process Development Forum …
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
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Implications of Cell Culture Conditions on Protein Glycosylation
These sites can then be analyzed using a number of techniques to determine the nature of the glycans at each site and the specific populations of the glycans on the biopharmaceutical molecule.
Refe…
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CMOs Continue to Improve Overall Biomanufacturing Performance
Results from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) offer some clues as to what CMOs are doing to remain competitive.
CMOs…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …