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Five Keys to Manufacturing Success

By R. J. Filannino, October 26, 2017

"...there are five dominant management systems required to achieve manufacturing performance.... Each element drives an important priority within the organization. An imbalance in any direction will create a gap and introduce unnecessary organization variation, impacting product quality."

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Optimizing Time to Market

By David Shenberger, June 20, 2017

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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How to Understand ASTM E2500