Search results for " development" in Articles / App Notes
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
To expedite the review of new manufacturing technologies, FDA has initiated efforts to promote early discussion between drug sponsors and the agency to address manufacturing design and development iss…
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The Tide Stays High
Because contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) get so much of their business from externally-financed companies, the negative energy su…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
This development will lead to the increasing availability of high quality single-use material information which, in turn, will provide greater technical insight to process performance. This will help …
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Biopharma in 2015: A Year for Approvals and Innovations
Of equal importance, some 57 biosimilar products for 16 reference products are enrolled in FDA’s Biosimilar Product Development program, and sponsors are seeking preliminary advice on another 27 proje…
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Selecting a Comprehensive Bioburden Reduction Plan
Kathleen Souza, senior microbiologist in the Department of Virology and Microbiological Sciences at EMD Millipore, and Nick Hutchinson, market development manager, pharma and biotech at Parker domnick…
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Quality Systems Key to Lifecycle Drug Management
These developments reflect the struggle for regulators trying to review thousands of supplements, and for manufacturers implementing changes in products and manufacturing facilities around the world. …
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A Bright Future for the Plasma Fractionation Industry
…full program with six scientific sessions focusing on issues and possibilities around manufacturing, development, and clinical use of plasma products in general. In addition, a poster session allowed…
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Continuous Chromatography: Trends, Definitions and Approaches
Can you comment on the importance of process development and control in the continuous process?
Process development and control are the two very important aspects related to continuous chromatogra…
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Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"We expect development of biosimilar drugs to continue at a rapid pace," says Senior Vice President, Michael Levesque. "But while in Europe more than a dozen products are now commercialized, in the US…