Abstract
The development of freeze-dried injectable pharmaceutical products has traditionally been a process of trial and error, both with respect to the composition of the formulation and the process conditions used during freeze-drying. Although this approach ultimately may result in an acceptable product, it is a time-consuming and labor-intensive process, and is unlikely to result in the highest quality product attainable or in a freeze-dry process which is optimized.
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Nail, S.L., Jiang, S., Chongprasert, S., Knopp, S.A. (2002). Fundamentals of Freeze-Drying. In: Nail, S.L., Akers, M.J. (eds) Development and Manufacture of Protein Pharmaceuticals. Pharmaceutical Biotechnology, vol 14. Springer, New York, NY. https://doi.org/10.1007/978-1-4615-0549-5_6
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