Search results for " information" in Articles / App Notes
Article
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),…
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Global Expansion Shapes Drug Oversight
…pediatric cluster meetings to encourage more common policies for pediatric studies and applications; information exchange by the EMA-FDA pharmacovigilance cluster; and broader cooperation related to …
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Challenges in Analytical Method Development and Validation
Using a pre-established set of parameters for method validation may be helpful in expediting the validation process, but it doesn’t necessarily provide relevant information about how the method will p…