Search results for " information"
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Biosimilar manufacturers begin the development of a process with a large information gap. So while the technology of manufacturing a biosimilar is largely the same as manufacturing an original biologi…
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Drug Quality Key to Innovation and Access
A broad industry group adopted guidelines on using the Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability of pharmaceuticals (3). Achieving stand…
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Advancing Single-Use Technology Through Collaboration
The end-user can use this information to determine worst-case scenarios for each assembly based on surface areas and contact times. A toxicologist can determine thresholds of toxicological concern for…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Suppliers that are several levels upstream do not always understand why this sort of information is important and may initially resist revealing their material sources or process details. They may obj…
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Design and Qualification of Single-Use Systems
US 21 CFR does provide some information for process equipment designers: Section 211.65, paragraph (a) states, “Equipment shall be constructed so that surfaces that contact components, in-process mate…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The analysis revealed that near-infrared spectra of different soy lots contain enough physicochemical information about soy hydrolysates to allow the identification of lot-to-lot variability as well a…
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mAbs to Watch in 2016
*The forecasted approval dates are drawn directly from company-disclosed information (e.g., press releases, company presentations, etc.). As such, there may be products that are filed or in Phase III …
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Breakthrough Drugs Raise Development and Production Challenges
The process, he explained at the April 2015 CMC workshop sponsored by the Drug Information Association (DIA), is resource intensive, and accelerated timelines necessitate new approaches to product and…
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Taking a “Development-by-Design” Approach to Cell Therapies
“Investing in automated information management can also pay off,” he says, “where an electronic batch record system that is fully validated can enable release-by-exception, reducing error, documentati…
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Continued Process Verification for Biopharma Manufacturing
The reward for this additional data collection and analysis is that CPV will provide information from which to improve process understanding, risk assessment/mitigation, and the control strategy (CS),…