Search results for "biopharm"
Article
Generating a Fully Processed Antibody
By Gregory Bleck, Dona York, David Rabuka
The number of more complex biopharmaceuticals in development continues to increase. These include molecules such as virus-like particle (VLP) vaccines, pr…
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Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
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Managing Biomanufacturing Capacity Expectations
According to a new survey by BioPlan Associates, more than half of respondents (60%) expect facility constraints to create biopharmaceutical production capacity constraints by 2021 (1). BioPlan found …
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Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals, such as lower capital investment and increased flexibility, are now well docu…
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Platform Approach Speeds Process Development
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
Commercial production of complex biopharmaceuticals such as recombinant monoclonal an…
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Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
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Lessons Learned Accelerate Vaccine Development
The biopharmaceutical industry is focused on accelerating the development of new vaccines for such diseases and enabling the rapid response to unforeseen appearances of new viral threats. The successe…
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Continuous Processing for the Production of Biopharmaceuticals
There have also been new efforts by various regulatory organizations to encourage continuous processing for the manufacturing of biopharmaceuticals. Both FDA and the European Medicines Agency (EMA) ha…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Cells used for biopharmaceutical applications are mainly of animal origin and can be cultured in suspension or adherent cell cultures. A unique characteristic of adherent cells is their dependence on …