Search results for " information"
Article
Using Quality by Design to Develop Robust Chromatographic Methods
If structures are known, then the experimental screening strategy may be supplemented by the information to be gleaned from a Log(P) vs. pH plot (P is the octanol water distribution coefficient of all…
Article
Applying GMPs to the BioPharma Supply Chain
Suppliers need to understand and apply the concept of corrective action preventive action (CAPA), and they need to be able to produce information and reports to support the paperwork trail.
Scient…
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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…
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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…
Article
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…
Article
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…