Bachem releases Case Study on White Paper on Octreotide Scale-Up

Bachem AG, the leading CDMO in development and manufacture of peptides and oligonucleotides, has published a case study that demonstrates how it has developed a cost-effective, large-batch process for generic Octreotide Acetate Synthesis.

Octreotide acetate is a therapeutic octapeptide analog of the naturally occurring hormone somatostatin. First approved for use in the United States in 1988, this longer-acting synthetic peptide agonist is used for the reduction of growth hormone and insulin-like growth factor 1 primarily used in adults with acromegaly. 95% of acromegaly cases are caused by tumors of the pituitary gland where surgical resection is often not possible, requiring life-long use of growth hormone (GH)-lowering therapy.

Outsourcing large scale production

The technical case study is based on experience gained during Bachem’s collaboration with a large generics pharmaceutical company who formerly manufactured octreotide in-house. Since partnering with Bachem, it has gained a solution for large-scale production of the API that overcomes many of the production challenges associated with Octreotide Acetate for pharmacological treatments that include persistence of symptoms and failure of biochemical control, as well as therapy regimens requiring daily injections.

GH-lowering therapy is associated with reduced quality of life (QOL) and higher economic burdens for patients.

New therapies such as oral formulations promise better disease control and quality of life for patients but require 30-60 times higher octreotide acetate concentrations, thus putting demand on complex API manufacturers such as Bachem to cost-effectively scale production.

The case study shows how this can be achieved.

Resources

Click on Leading the Octreotide Scale-Up: A Generics Case Study to view or download case study paper.
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