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Scaling up production of an octapeptide therapeutic with solid phase synthesis

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Overview

Octreotide acetate is a therapeutic octapeptide analog of the naturally occurring hormone somatostatin. First approved for use in the United States in 1988, this synthetic peptide agonist is primarily used to treat adults with acromegaly. Most patients with acromegaly require life-long use of hormone therapy. New therapies such as oral formulations promise better disease control and quality of life for patients, but require 30-60 times higher octreotide ace¬tate concentrations, thus putting demand on complex active pharmaceutical ingredient manufacturers to cost-effectively scale production.

Learn how one pharmaceutical manufacturer used solid phase peptide synthesis to scale up octreotide acetate production 15-fold, producing validated product from the new process within 22 months.

Key Objectives:

How to make complex peptides at quality and scale
Upscaling octreotide acetate synthesis in a short timeline
Addressing regulatory services

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