Search results for " industry"
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Perfusion in the 21st Century
Within the past decade, however, changes in the biopharmaceutical industry and advances in perfusion technology have increased its rate of adoption. Many drugs have or will soon come off patent, incre…
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A Q&A with Eric Langer: CMOs Embrace New Technology
What was the most surprising trend revealed in the 13th Annual Report and Survey of BioManufacturing? Why?
The bioprocessing industry, as a regulated environment, does not adopt novel approaches…
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Downstream Processing Continues to Worry CMOs
Perhaps as a result, the industry’s demand for new chromatography products appears to have slightly abated. This year, chromatography products ranked 6 out of 23 new product development areas of inter…
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Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Today’s industry and regulatory expectations require that an effective viral risk mitigation strategy be built into the whole manufacturing chain, spanning from the suppliers of crucial raw materials …
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
…Tripartite Guideline Validation of Analytical Procedures: Text and Methodology, and FDA Guidance for Industry, Bioanalytical Method Validation (18, 19, 20). The parameters of the validation included …
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Vaccine Development Faces Urgency and Challenges
Scientific advances
To achieve these goals, scientists in academia, government, and industry are moving to tap new genomics technology to reduce the long R&D process and help modernize vaccine dev…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…ant proteins have been the most important factors that have enabled the adoption of CHO cells as the industry’s predominant host for development and manufacturing of therapeutic proteins (17). Howeve…
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Innovative Therapies Require Modern Manufacturing Systems
FDA, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry, Draft Guidance (CDER, December 2015).
5. US House of Representatives …
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GMP Challenges for Advanced Therapy Medicinal Products
“[This is] weakening the position of the EU academics and industry to collaborate and compete globally in this expanding field.”
Advanced medicines may need the adoption of a different strategy to …