Quality by design for biopharmaceuticals

@article{Rathore2009QualityBD,
  title={Quality by design for biopharmaceuticals},
  author={Anurag Singh Rathore and Helen Winkle},
  journal={Nature Biotechnology},
  year={2009},
  volume={27},
  pages={26-34}
}
The US Food and Drug Administration's 'quality by design' approach is likely to transform the manufacture of biologics. 

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References

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TLDR
Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications into a science-based pharmaceutical quality assessment.

Application of Multivariate Analysis toward Biotech Processes: Case Study of a Cell‐Culture Unit Operation

TLDR
The feasibility of using multivariate data analysis (MVDA) for supporting some of the key activities that are required for successful manufacturing of biopharmaceutical products is examined, demonstrating the effectiveness of MVDA as a tool for extracting process knowledge.

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

TLDR
It is shown that implementing this analytical scheme allows us to meet two of the key goals that have been outlined for PAT, that is, “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions.