Search results for " drug"
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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
It has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by FDA as part of Phase I, Phase I…
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High-concentration monoclonal antibody drugs: manufacturing challenges
The growth in the formulation of drugs suitable for delivery by subcutaneous (Sub-C) injection highlights manufacturing challenges associated with the higher concentration of active ingredient…
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Ensure SEC Column Reproducibility in Protein Drug Analysis
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you…
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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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Milestones and Moderate Progress in 2012 Drug Approvals
Until 2012, no gene therapy-based product had gained approval for human use in the western world, although a small number of such products have been approved in China (5) and four gene therapy-based d…
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State Food and Drug Administration, P.R. of China
China's regulatory organization overseeing drugs, medical devices, health food and cosmetics, as well as food safety .
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Parenteral Drug Association
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded i…
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A better way to purify small drug volumes
Viral vectors: demand is high and getting higher. But purifying viral vectors with methods optimized for other products can affect yield, purity, and cross-contamination.
How does the …
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Emerging biopharma: progressing a biologic drug to market
There are many pitfalls in the road to developing and bringing a new therapy to market. Understanding some of these areas and being prepared to make the right decisions at the right ti…
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Tackling Analytical Method Development for ADCs
Both small and large
As for any drug, analytical methods for the characterization of ADCs must be developed, and separate quality control (QC) tests must be established for lot release of the fina…