Search results for " emerging biotech"
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
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From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …
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Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
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Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
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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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Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
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Developing a New Biologic Drug: Regulatory Challenges and Considerations
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Key milestones and planning ahead for compliance when bringing a new biologic drug to market
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Basics in Process Development for Biotherapeutics
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Definitions, activities, and things to consider when developing an upstream or downstream bioprocess.
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Testa Challenge 2020 Attracts Leading International Bioprocessing Innovators
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Six bioprocessing innovators have successfully completed the inaugural Testa Challenge 2020. Held over an intensive week in the Testa Center located at Cytiva´s Uppsala…