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Structure-Function Relationships for Recombinant Erythropoietins: A Case Study From a Proposed Manufacturing Change With Implications for Erythropoietin Biosimilar Study Designs.

Abstract：

:Comparability studies used to assess a proposed manufacturing change for a biological product include sensitive analytical studies to confirm there are no significant differences in structural or functional attributes that may contribute to clinically meaningful changes in efficacy or safety. When a proposed change is relatively complex or when clinically relevant differences between the product before and after the change cannot be ruled out based on analytical studies, nonclinical and clinical bridging studies are generally required to confirm overall comparability. In this study, we report findings from a comparability assessment of epoetin alfa before and after a proposed manufacturing process change. Although differences in glycosylation attributes were observed, these were initially believed to be irrelevant to the product's pharmacology. This assumption was initially supported via nonclinical and clinical pharmacology studies, but a clinically meaningful difference in potency was ultimately observed in a phase 3 clinical study conducted in a sensitive patient population using a sensitive study design. These results indicate that the nonclinical assessments of structure-function relationships were insufficiently sensitive to identify clinically relevant differences resulting from differences in the glycosylation profile. This case study highlights important findings that may be relevant in the development of biosimilar epoetin alfa products.

journal_name

J Pharm Sci

journal_title

Journal of pharmaceutical sciences

authors

Grampp G,McElroy PL,Camblin G,Pollock A

doi

10.1016/j.xphs.2018.01.018

subject

Has Abstract

pub_date

2018-06-01 00:00:00

pages

1512-1520

issue

6

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(18)30042-X

journal_volume

107

pub_type

杂志文章,多中心研究,随机对照试验

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