Search results for " information" in Articles / App Notes
Article
The Affordable Care Act's Impact on Innovation in Biopharma
…al companies must understand the clinical and economic data these decision makers value and how this information can be communicated to them in an effective manner. In a world of new payment models a…
Article
FDA Seeks Metrics to Define Drug Quality
12, 2013
Federal Register notice (1), FDA solicited such information, and manufacturers and industry trade associations submitted comments describing a variety of industry standards and quality as…
Article
QbD and PAT in Upstream and Downstream Processing
Rathore (IIT Delhi): Implementation of QbD necessitates creation of information relating the process to the product and the product to the clinic. It is this understanding that lays the foundation for…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
…evaluating clinical data, manufacturing operations, and procedures for submitting and analyzing information.
Most visible have been the many changes in the conduct of preclinical and clinic…
Article
Using Digital Twins to Model Process Chromatography
To predict the impact on process performance, a profound understanding of the differences with respect to material, system, and operation is required, though fortunately obtaining this required inform…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
…n numbers (GLNs) for physical locations, and share data electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping t…
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Remote Monitoring and Big Data Advance Upstream Automation
“The convergence of information technology with operational technology, PLM, and the implementation of digital threads is breaking down the traditional silos of past automation architectures,” Navarro…
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Good Manufacturing Practices: Challenges with Compliance
Cohen (Lubrizol): There are various regulations and guidelines around the world regarding the manufacture of biologics, which include information about control of feedlots and cell lines. These addres…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
For example, the bioprocess model would have to capture relevant information consistently as well as thoroughly to allow both researchers and IT developers understand the process requirements. The mod…
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Cell-Culture Advances Test Bioreactor Performance Models
In addition, the information systems technology used has been validated and demonstrated to be cost effective, secure, compliant, and scalable with the volume of data generated from manufacturing proc…