Search results for "Streamline"
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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
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Transformative Medicines Challenge FDA and Manufacturers
FDA has been working to explain and streamline the process for meeting manufacturing standards for both components, as seen in guidance that was finalized in January 2017 (1); further clarification of…
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What You Need to Know about Continuous Processing
There is a lot of interest around continuous biomanufacturing, and it is expected to have a significant impact on the biomanufacturing industry over the next few years. Continuous processing can hel…
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Avoiding Investigational Failures and Discrepancies
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Simplified tracking, trending, and report creation
Optimized quality processes and streamlined implementation of preventive measures.
Conclusion
Investigational failures a…
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Reconciling Sensor Communication Gaps
Whatever techniques are ultimately adopted, their ultimate goal must be to eliminate manual sampling and lengthy analyses, or at least, to streamline these operations so they become relevant within th…
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Drug Quality Key to Innovation and Access
Expanded global sourcing of pharmaceutical ingredients and products will continue to build support for regulatory mutual reliance initiatives able to streamline agency oversight while assuring quality…
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Biosimilars to Drive Modern Manufacturing Approaches
These efforts will be supported by a new agreement on policies for renewing the Biosimilar User Fee Act (BsUFA II), with provisions to streamline the biosimilar development and approval process (1). T…
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Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Strategy and algorithm for specific identification of culture media
Based on the acquired data and established specifications discussed in the previous section, a streamlined approach to identity …
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Vaccine Development Faces Urgency and Challenges
Manufacturing challenges
In addition to support for innovation to achieve a sustainable and profitable vaccine industry, manufacturers hope to gain more streamlined vaccine development requirement…