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 the proportion of patients who developed antidrug antibodies (ADAs) after treatment. Eighty-two patients were enrolled. The mean (SD) treatment duration was 347 (53) days. The incidence of ADAs was 3.7%. No neutralizing antibodies were observed in the three patients with ADA-positive samples. Two patients (2.6%) had growth attenuation, but they were not ADA positive. The manufacturing changes for somatropin version 1.1 resulted in a similar safety and efficacy profile compared with somatropin version 1.0 and a different immunogenicity profile with a lower incidence of ADAs.

中文翻译：

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生物疗法生产过程的变化可以改变产品的免疫原性。

制造工艺的改变可能会改变蛋白质治疗剂的特性。2009年，重组人生长激素治疗剂生长激素（1.0版）进行了生产更新（1.1版）。2014年，在一项针对未治疗的患有特发性人类生长激素缺乏症的小儿患者进行的为期1年的前瞻性，开放标签，单臂临床研究中，评估了生长激素1.1版每天皮下注射的免疫原性。主要终点是治疗后产生抗药物抗体（ADAs）的患者比例。入选了82例患者。平均（SD）治疗时间为347（53）天。ADA的发生率为3.7％。在三名ADA阳性样本的患者中未观察到中和抗体。两名患者（2.6％）的生长减弱，但他们对ADA并不满意。与1.0版生长激素相比，1.1版生长激素的生产变化导致了相似的安全性和功效特征，不同的免疫原性分布导致ADA发生率降低。