Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals - The principles of QbD can be applied to biotech development and manufacturing to help resolve many

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Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals
The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues.


BioPharm International
Volume 21, Issue 5

Perhaps the biggest obstacle to the adoption lies in the industry's unfamiliarity with the tools and methods that QbD uses to achieve comprehensive product and process knowledge and control: high-end statistics (i.e., multivariate analysis), modeling tools, design of experiments, etc. These tools have been used for decades in the chemical, engineering, and high-technology industries, and taught in graduate programs that lead to those industries. Graduate programs in life sciences do not universally teach these skills and they are not fully integrated and applied in the life sciences industries. As a result, many biotech industry scientists are simply unaware of the power, applicability, and track record of these powerful techniques.

That is about to change, as biotech companies seek innovative ways—including QbD—to respond to the multiple pressures and trends sweeping the industry. It is those QbD tools that are used to determine the all-important Design Space, defined in ICH Q8 as "the multi-dimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality."2 How those tools work to describe that linkage between the process inputs and the critical quality attributes (CQAs) is the subject of the next installment in this series.

Conrad J. Heilman, Jr., PhD, is senior vice president at Tunnell Consulting, King of Prussia, PA, 610.337.0820,

REFERENCES

1. Rathore AS, Johnson R, Yu O, Kirdar AO, Alaqappan A, Ahuja S, Ram K. Applications of multivariate data analysis in biotech processing. BioPharm Int. 2007 Oct;20(10).

2. International Conference on Harmonization. Q8, Pharmaceutical development. Geneva, Switzerland; 2005.


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