Search results for " patients" in Articles / App Notes
Article
Securing the Single-Use Supply Chain
“Single-use customers recognize that it is difficult to fully control the supply chain, which presents a potential risk to their operations and subsequent supply of needed drugs to patients,” Acucena …
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New Era for Generic Drugs
The legal battle is escalating as brand manufacturers seek to avoid added liability for patients harmed by generic drugs, and generic-drug companies insist they can’t have labels different from the br…
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Predicting Progress in Protein Aggregation
The behavior of the formulated product once administered to patients must also be considered, because protein aggregation can occur in the human body as well (e.g., Alzheimer’s disease is caused by pr…
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State of Quality and Compliance in the Biopharmaceutical Industry
There needs to be a shift in thinking, attitudes, and behaviors so we don't place our companies, employees, and patients at risk when getting things done "now" is valued more than doing what is best f…
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Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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Impurity ELISA automation for faster process development
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step can…
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A Closer Look at Affinity Ligands
The single-domain heavy chain antibody fragments from Camelidae have also been utilized successfully as affinity ligands for purification coagulation factors to help patients with hemophilia type A an…
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Boosting biopharma resilience: The need to shift focus and increase collaboration
Specifically, he’ll highlight where the industry should turn their focus to ensure that patients are continuing to get the essential life-changing therapies they need.
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