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    Quality by design (QbD) involves a science-based approach for developing drugs that is highly supported by the FDA. A robust QbD process requires an intimate understanding of the product characteristics and manufacturing process so that manufacturers can understand which aspects of the product/process are critical and which can be changed with minimal impact.

    Articles

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    Phase change material in cold chain packaging offers big benefits, but getting there requires a data driven approach
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    Droplet digital PCR technology strengthens quality control during CAR-T cell production
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    At its core, the approach looks to design quality into workflows up front.
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    The integration of scientific rationale supports the probabilistic modeling approach that is required for effective QbD implementation

    News

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    Interviews with product experts about select hardware/software products applicable to PAT/QbD, highlighting key features of each instrument/program
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    Advances in instrumentation and techniques for critical quality attribute characterization are increasing the applicability of platform high-performance liquid chromatography ...
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    Advanced technology and rising healthcare costs have driven notable changes in inhalation therapy
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    New formats and formulations will change CMC requirements
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    The FDA has approved -- for the first time in history -- a manufacturer’s production method change from “batch” to continuous manufacturing.
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    The optimization and scale-up of wet granulation processes is often an essential step in the commercialization of oral solid dosage (OSD) products. Granulation enables the preparation...