Microencapsulation Methods for Delivery of Protein Drugs

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226 Biotechnol. Bioprocess Eng. 2001, Vol. 6, No. 4 effect and incomplete release behavior. As an ideal burst technique, one should satisfy the follow- encapsulation conditions. First, the manufacturing conditions ing be mild enough to conserve the protein stability should the process. Oil-water interface, shear forces, or during may be major causes of protein denaturation and heat Second, high encapsulation efficiency is aggregation. Even if the progress of genetic engineering important. many therapeutic proteins available at a lower made than before, protein drugs are in general much price expensive than other low molecular drugs. Third, more is preferable to minimize the exposure to toxic or- it solvents. Fourth, the manufacturing process ganic be reproducible and easy to scale up to the should scale. Also, aseptic manufacturing should commercial available. Fifth, in order to ensure product quality as be injectable formulation, uniform size distribution of an microparticles should be achievable. the numerous novel protein drugs coming Considering the genome projects, new microencapsulation sys- from that minimizes use of toxic organic solvents and tems denaturating conditions will be invaluable tools protein the future, and this is an exciting time to be involved in the microencapsulation technology. in REFERENCES Thies, C. (1996) A survey of microencapsulation proc- [1] pp. 1-19. In: S. Benita (ed.). Microencapsulation: esses. and Industrial Applications. Marcel Dekker, Inc., Methods York, USA. New Wang, H. T., E. Schmitt, D. R. Flanagan, and R. J. Lin- [2] (1991) Influence of formulation methods on the in hardt controlld release of protein from poly(ester) micro- vitro J. Controlled Release 17: 23-32. spheres. Pradhan, R. S. and R. C. 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