Applied advanced process analytics in biopharmaceutical manufacturing: Challenges and prospects in real-time monitoring and control

Author:

Ündey Cenk,Ertunç Sinem,Mistretta Thomas,Looze Bryan

Publisher

Elsevier BV

Subject

Industrial and Manufacturing Engineering,Computer Science Applications,Modelling and Simulation,Control and Systems Engineering

Reference28 articles.

1. The Biotechnology Market Outlook: Growth Opportunities and Effective Strategies for Licensing and Collaborations;Business Insights,2005

2. Pharmaceutical cGMPs for the 21st Century: A Risk-based Approach;US Food and Drug Administration,2002

3. Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance;US Food and Drug Administration,2004

4. Guidance for Industry: Q10 Quality Systems Approach to Pharmaceutical cGMP Regulations;US Food and Drug Administration,2009

5. Characterizing biological products and assessing comparability following manufacturing changes;Chirino;Nat. Biotechnol.,2004

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