Search results for " patients" in Articles / App Notes
Article
Milestones and Moderate Progress in 2012 Drug Approvals
The committee appeared initially to have a number of product quality-related and efficacy-related concerns, and final product approval is restricted to a subset of LPL-deficient patients suffering the…
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A Look Ahead at BioPharma Manufacturing and Regulation
Modernizing manufacturing approaches for pharmaceuticals, such as through QbD, continuous manufacturing, and/or PAT, has the potential to benefit industry, regulators, and patients. Already, there hav…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
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The Importance of Partnering for Bioanalytical Studies
They can also be used to stratify patients to predict responders or non-responders. Another key bioanalytical assay for biotherapeutics is the assessment of immunogenicity (both wanted and unwanted).…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
In addition, a resolution to the Brexit crisis is needed in Europe in order for companies and patients to have greater certainty about the future regulation and supply of drugs.
Noonan (MBHB): T…
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Biosimilar Quality Requirements
The pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, increasing access to life-saving medications, and potentially lo…
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Best Practices for Selecting a Top-Quality Cell Line
…l contaminants, but should contain one to four copies of the CAR gene (more than four copies exposes patients to the toxic effects of T cells, which include organ dysfunction and death).
One o…
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Tools and Processes for Mature and Emerging Therapies
The one patient–one treatment approach using current biologic manufacturing processes is not sustainable for large groups of patients. The likelihood that manufacturing gene therapies or cell therapi…
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Moving PAT from Concept to Reality
PAT can account for the variations and peculiarities of the cells from different patients in an automated fashion, enabling a high process consistency irrespective of the starting material.
PAT ca…