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Biotech R&D Demanding New Analytical Techniques, Technologies

Biotech R&D Demanding New Analytical Techniques, Technologies

    investment in biotech R&D is reportedly now outpacing that of big pharma (http://www.burrillandco.com/content/news/PR-BIO-2013-4-16-13-final.pdf ) and is driving rapid developments across the biopharmaceuticals sector.

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    Using Quality by Design to Optimize Tech Transfer of a Blow-Fill-Seal Process

    Using Quality by Design to Optimize Tech Transfer of a Blow-Fill-Seal Process

      By Norman Weichbrodt and Mike Camalo, Catalent Pharma Solutions

      Technology transfer is a difficult and sensitive process.  For a drug service supply partner, transferring an existing drug product from a customer’s facility to its own manufacturing plants offers an opportunity to increase value by improving process efficiencies and equipment design, and to incorporate operational excellence principles into the work.

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      Quality by Design, Part 2

      Quality by Design, Part 2

        In part one of this two-part series, quality by design was discussed as a business problem involving successive gaps in new product introduction. A five-phase architecture was introduced. Part two looks at the last two elements of this architecture, customer-focused optimization and dominance over variability.

        Customer-focused optimization

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        QbD Implementation in the Generics Industry:  Overview and Teva Case Study

        QbD Implementation in the Generics Industry: Overview and Teva Case Study

          As generic pharmaceutical manufacturers work to find the balance between speed, efficiency and product quality excellence, QbD approaches are playing an important role.

          Inna Ben-Anat, QbD Strategy Leader, Teva Pharmaceuticals, at IFPAC 2013 walked through the merits of QbD in meeting the challenges generic manufacturers face.  He also presented a compelling case study from Teva Pharmaceuticals’ experiences.

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          Analytical Methods & QbD: A Perfect Match

          Analytical Methods & QbD: A Perfect Match

            By David LeBlond

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            QbD-Based RTR: A Systems Engineering Approach

            QbD-Based RTR: A Systems Engineering Approach

              by Jose Menezes, 4TUNE Engineering

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