Search results for " review"
Article
Getting your investigational drug regulatory ready
In this article, we outline some basic information and helpful strategies to facilitate efficient drug review.
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Master the basics of UNICORN™ method editing with a free online course
This free interactive course explains how to create and edit methods in
UNICORN™ software for ÄKTA™ chromatography systems.
Review the basics and learn how to use predefined phases…
Article
mRNA Global Alliance Tests the Waters at BIO
World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Additionally, it is important to review how the iron carriers are mined and how they were synthesized for the salts which were added. It helps create a good dialogue between the vendors and us in orde…
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Maximum Output Starts with Optimized Upstream Processing
“Expanding our digital capabilities has been important in the pursuit of big data analytics that has enabled efficient and effective development, analysis, and review of significant quantities of data…
Article
Getting Your Investigational Drug Regulatory Ready
This article outlines basic strategies for efficient regulatory review and drug approval.
Article
Virus-like Particles as Therapeutic Moieties of the Future
In this 44th article in the “Elements of Biopharmaceutical Production” series, the authors review the status of VLPs as therapeutics as well as challenges associated with their analytical and function…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
It provides guidance on the development of COVID-19 treatments; it reviews and requests data from developers; and it works as an advisor to the Scientific Advice Working Party (SAWP)/Committee for Med…
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Eliminating Residual Impurities Starts with a Strategic Plan
Such a document should be reviewed regularly and serve as a repository for information as the project moves from early- to late-stage development,” he states.
Finding suitable evaluation criteri…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Taylor, European Biopharmaceutical Review, pp. 24–28 (2019).
12. HemaCare, “HemaCare Details Expanded GMP Capabilities at CAR-TCR Summit in Boston, MA.,” Press release, Sept. 4, 2018.
13. C.…