Ontology highlight
ABSTRACT:
SUBMITTER: Vanderlaan M
PROVIDER: S-EPMC7158213 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
Clinical pharmacology and therapeutics 20191211 4
Manufacturing process changes may alter the characteristics of a protein therapeutic. In 2009, somatropin (version 1.0), a recombinant human growth hormone therapeutic, underwent a manufacturing update (version 1.1). The immunogenicity of somatropin version 1.1 as a daily subcutaneous injection was evaluated in 2014 in a prospective, open-label, single-arm clinical study of treatment-naive pediatric patients with idiopathic human growth hormone deficiency for 1 year. The primary end point was th ...[more]