Search results for "innovation"
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Reliability Rooms and the Move to Proactive Supply Chain Management
Generally, the RRs track data on suppliers’ quality, delivery, cost and risk profile, technology usage, innovation, audit results, and strategic alignment. In some cases, their internal performance is…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
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Platform Technologies Improve Protein Expression
…veraging capabilities and capacities, notes Beate Mueller-Tiemann, head of business integration and innovation at Sanofi. “Consequently, platform expression technologies may lead to substantial benef…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
This will be part of a comprehensive Innovation Initiative, Commissioner Scott Gottlieb announced in July in presenting FDA’s plan for implementing the 21st Century Cures Act (2). New guidance documen…
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Patenting Prospects for Cell-Based Therapies
Indeed, it may be the case that regulatory exclusivity—analogous to the 12-year market exclusivities for biologic drugs provided by the Biologics Price Competition and Innovation Act (BPCIA)—will be m…
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Bioburden Control in the Biopharmaceutical Industry
Walker, “Innovation at the Heart of Biopharmaceutical Industry Growth,” www.americanpharmaceuticalreview.com/Featured-Articles/187354-Innovation-at-the-Heart-of-Biopharmaceutical-Industry-Growth, acce…
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Process Chromatography: Continuous Optimization
Metal chelate, size-exclusion, and hydroxyapatite resins are also used on a limited basis, according to Andrew Bulpin, head of process solutions strategic marketing and innovation with MilliporeSigma.…
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Contract Manufacturing Through the Years
A second development to watch is how the industry has bifurcated into two major segments as it has matured: innovation-driven CDMOs that offer the most sophisticated capabilities and get…
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Hybrid Bioprocessing: A Q&A with Andrew Sinclair
Process Development Forum speaks about hybrid bioprocessing with Andrew Sinclair, President and Founder of BioPharm Services
How would you define hybrid bioprocessing?
Hybrid processing is n…