Elements of Quality by Design in Development and Scale-Up of Freeze-Dried Parenterals - - BioPharm International

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Elements of Quality by Design in Development and Scale-Up of Freeze-Dried Parenterals


BioPharm International
Volume 21, Issue 1

SUMMARY

It is important to view product and process development for freeze-dried parenterals as an integrated process rather than as a collection of independent activities. When doing formulation and initial cycle development, the development scientist must be aware of the type of equipment to which the product will be transferred in the next stage of development. The scientist must also understand the capability of the equipment, and must take it into account as cycle conditions are developed. This approach becomes particularly important for formulations that will withstand aggressive cycle conditions.

To generate a design space similar to the one in this discussion, it is necessary to have a thorough understanding of both the characteristics of the formulation and the capability of equipment. This is the major intent of the Quality by Design paradigm.

Steven L. Nail, PhD, is a senior Baxter research scientist at Baxter Pharmaceutical Solutions, Inc., Bloomington, IN, 812.355.7270, steven_nail@baxter. Jim A. Searles, PhD, is director of development at Aktiv-Dry, LLC, Boulder, CO.

REFERENCES

1. Design space to facilitate qality initiative implementation. The Gold Sheet. 2005 Apr;39 (4).

2. Gieseler H, et al. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying. J Pharm Sci. 2007;96:1776–93.

3. Chang BS, Fischer NL. Development of an efficient single-step freeze-drying cycle for protein formulations. Pharm Res. 1995;12:831–7.

4. Nail SL. The effect of chamber pressure on heat transfer in the freeze-drying of parenteral solutions. J Parenteral Drug Assoc. 1980;34:358–68.

5. Searles JA. Observation and implications of sonic water vapor flow during freeze-drying. Amer Pharm Rev. 2004;7 (2):58–69.


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