Search results for " drug"
Article
Impurity Testing of Biologic Drug Products
“Variants also include forms of the therapeutic proteins in solution that are different from the intended drug product (i.e., different conformation or aggregation state). They can also be identified …
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Yet, there is increasing pressure on the industry to reduce the price of these drugs. One possibility is in the development of biosimilar products. President Trump has promised to repeal and replace t…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
FDA approved 17 biologics out of a total of 59 drugs—the highest number to date.
This article will delve into why the pharma industry is heading toward a biologics revolution, what challenge…
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An Analytical Approach to Biosimilar Drug Development
For immunogenicity assays, the current industry practice is also to use a single assay, with the biosimilar as a capture reagent (and as the conf irmatory drug) when assessing antidrug antibody (ADA) …
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Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
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Getting it Right from the Start in the Drug Development Process
Both upstream processing and downstream processing can affect critical quality attributes of the drug molecule under development. These effects can result in process-related impurities, product impuri…
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Getting your investigational drug regulatory ready
From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline …
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Two examples are the International Site for Pharmaceutical Engineers and the Parenteral Drug Association, which have a lot of different guidelines or technical reports that are developed by groups of …
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Getting Your Investigational Drug Regulatory Ready
This article outlines basic strategies for efficient regulatory review and drug approval.