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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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An Integrated Downstream Process Development Strategy along QbD Principles.

Andrea Meitz1, Patrick Sagmeister2, Timo Langemann3,4

  • 1Research Center of Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria. andrea.meitz@tuwien.ac.at.

Bioengineering (Basel, Switzerland)
|September 29, 2017
PubMed
Summary
This summary is machine-generated.

This study introduces a new strategy for bioprocess development, using an interaction matrix and design of experiments (DoE) to manage critical process parameters across unit operations efficiently. It helps identify complex interactions, like Triton X-100 concentration and centrifugation, for improved protein purification.

Keywords:
design of experimentsinclusion body purityinteraction across unit operationsprocess developmentquality by designrisk assessment

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Area of Science:

  • Biopharmaceutical Process Development
  • Chemical and Biochemical Engineering
  • Quality by Design (QbD) Principles

Background:

  • Downstream process development faces challenges due to numerous critical process parameters (CPPs) across multiple unit operations.
  • Investigating CPPs and their interactions requires extensive lab-scale experiments, increasing time and resource demands.

Purpose of the Study:

  • To present a novel strategy for efficient bioprocess development by assessing and managing risks of parameter interactions across unit operations.
  • To introduce an interaction matrix tool within the Quality by Design (QbD) workflow for risk assessment.

Main Methods:

  • Development of a novel risk assessment tool (interaction matrix) to rate the risk of interactions between process parameters across unit operations.
  • Implementation of a design of experiments (DoE) strategy across unit operations to identify multivariate interdependencies.
  • Application of the strategy to protein isolation steps in an inclusion body (IB) process, focusing on inclusion body purity.

Main Results:

  • Demonstrated the strategy's effectiveness in identifying interactions between CPPs across unit operations.
  • Identified a specific interaction between Triton X-100 concentration and centrifugation g-number during inclusion body purification, impacting purity.
  • Showcased the strategy's ability to handle a high number of parameters with minimal experimental effort.

Conclusions:

  • The presented strategy offers a holistic approach to bioprocess development, effectively managing complex parameter interactions.
  • The QbD-integrated strategy enables efficient experimental design and optimization for downstream processes.
  • The methodology is generically applicable for bioprocess development adhering to QbD principles.