Search results for " capacity"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Several suppliers reported facility expansions to increase capacity for these vital materials. The new facilities offer operations that are similar to existing facilities; these redundant operations w…
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Platform Approach Speeds Process Development
Because antibody therapies may require large doses over a long period of time, manufacturing capacity becomes an issue because the drug substance must be produced in large quantities with cost and tim…
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Vaccine Development Faces Urgency and Challenges
At a Ministerial Conference on Immunization in Africa in February 2016, officials emphasized the need for greater funding of national immunization programs, including expanded regional capacity for va…
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Continuous Processing for the Production of Biopharmaceuticals
The whole assembly had the capacity to produce end-to-end continuous production from bioreactor to the polished product (Figure 2). The key distinguishing features of this facility were uninterrupted …
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Evaluation of transgene distribution profiles in CHO cell lines
The inherent adaptive ability of CHO cells and their capacity for the expression and secretion of recombinant proteins have been the …
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Biopharma in 2015: A Year for Approvals and Innovations
…iters of Monoclonal Antibodies
Trends in Single-use Bioreactors
Process economy and production capacity using single-use versus stainless steel fermentation equipment
A Bright Future for the…
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CMOs Concerned With Cost of Single-Use Equipment
BioPlan Associates, 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (Rockville, MD, April 2015), www.bioplanassociates.com/12th
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Some of the reasons leading to supply shortages could be increased market demand, poor product quality and/or GMP practice, increasing regulatory expectations, or limited or competing manufacturing ca…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
…e because the modular nature of the system enables point-of-use increases or decreases in production capacity. “This ambitious project has extended the benefits for the most critical unit operation--…