Current views on N-glycolylneuraminic acid in therapeutic recombinant proteins.
Trends Pharmacol Sci
; 42(11): 943-956, 2021 11.
Article
en En
| MEDLINE
| ID: mdl-34544608
ABSTRACT
The incorporation of the non-human N-glycolylneuraminic acid (Neu5Gc) in therapeutic recombinant proteins raises clinical concerns due to its immunogenic potential and the high prevalence of pre-existing anti-Neu5Gc antibodies in humans. The scientific literature is ambiguous regarding the actual impact of Neu5Gc-containing biotherapeutics as no severe adverse clinical manifestations were unequivocally attributed to Neu5Gc for currently marketed biotherapeutics. This review discusses structural and functional considerations of Neu5Gc-containing glycans regarding the potential impact on drug clearance, their recognition by pre-existing antibodies, and recent hypotheses regarding the tolerance to low Neu5Gc levels. Furthermore, it provides recommendations regarding the standardization of analysis and reporting, analytical aspects relevant for assessing risks associated with Neu5Gc-containing biotherapeutics, and approaches to minimize Neu5Gc incorporation in recombinant protein manufacturing.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Anticuerpos
/
Ácidos Neuramínicos
Tipo de estudio:
Guideline
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Trends Pharmacol Sci
Año:
2021
Tipo del documento:
Article
País de afiliación:
Italia