Search results for " business impact analysis"

Article Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity. Significant growth in the develo…

Article Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming. By Cynthia A. Challener As upstream processing drives toward higher efficiencies in meeti…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
As we began 2020, no one could have foreseen that just a few weeks into the year, we would be facing a pandemic threatening unprecedented damage to human health and the world economy. Businesses are…

Article Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain. Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…

Article Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …

Article The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges. By Kelvin H. Lee and Mark Lies …

Article Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach. By Cynthia A. Ch…

Article Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run. By Cynthia A. Challener  MG/Stock.Adobe.com …

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