Nature Medicine
2, 795 - 799 (1996)
doi:10.1038/nm0796-795
A month−long effect from a single injection of microencapsulated human growth hormoneOluFunmi L. Johnson1, Jeffrey L. Cleland2, Hye Jung Lee1, Margarita Charnis1, Eileen Duenas2, Warren Jaworowicz1, Douglas Shepard1, Azin Shahzamani2, Andrew J.S. Jones2
& Scott D. Putney1, 3
1Alkermes, Inc., 64 Sidney Street, Cambridge, Massachusetts 02139, USA
2Genentech, Inc., 460 Point San Bruno Boulevard, South San Francisco, California 94080, USA
3Correspondence should be addressed to S.D.P. An injectable sustained−release form of human growth hormone (hGH) was developed by stabilizing and encapsulating the protein, without altering its integrity, into biodegradable microspheres using a novel cryogenic process. A single injection of microspheres in monkeys resulted in elevated serum levels of recombinant hCH (rhGH) for more than one month. Insulin−like growth factor−I (ICF−I) and its binding protein IGFBP−3, both of which are induced by hGH, were also elevated for four weeks by the rhGH containing microspheres to a level greater than that induced by the same amount of rhGH administered by daily injections. These results show that, by using appropriate methods of stabilization and encapsulation, the advantages of sustained−release formulations previously demonstrated for low−molecular−weight drugs can now be extended to protein therapeutics.
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