Search results for " safety"
Article
Climate Change in Outsourcing
…of-of-concept (POC) model, which calls for minimizing development efforts until there is evidence of safety and efficacy in human subjects. POC is leading to specialization in the CMC (chemistry, man…
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Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
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Supplier-Change Management for Drug-Product Manufacturers
Additional Concerns for Critical Suppliers
For materials or services with a high potential to affect product quality and/or patient safety, a more formal and detailed contract may be required to d…
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Essentials in Establishing and Using Design Space
Tolerance design can be done either with statistical distributions (when low risk and no safety issues) and/or with transfer functions (how X influences Y). Establishing a design space allows for the …
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Prescribing Caution for Biosimilars
We welcome the opportunity to further discuss this issue with lawmakers as they seek to address vital drug safety measures that accompany this cutting-edge technology.
James C. Greenwood, Presiden…
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The Development and Application of a Monoclonal Antibody Purification Platform
In these cases, there were occasional issues surrounding virus clearance, raising safety concerns especially for antibodies required in large doses. To address these issues and increase the robustness…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Robotic liquid samplers can increase reproducibility, efficiency, and safety compared to manual handling of samples.
The final steps to most characterization workflows include data analysis and…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
By utilizing the instructions available in the UNICORN software for the ÄKTAcrossflow platform, a safety measure was incorporated into the method to prevent loading sample onto a fouled filter, r…
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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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FDA’s Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biolog…