Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials.

ABSTRACT:

Objectives

Aggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosimilar), addressing the physical and chemical stability with respect to aggregation and fragmentation.

Methods

The stability of residual PF-06439535 solution (25 mg/mL) after withdrawal of 80% (12.8 mL) filling volume with a 20G needle was monitored over a light-protected storage period of 8 days at 2-8°C and 25°C with measurement time points at D0 (start of storage), D2, D4, and D8 (2, 4, and 8 days of storage after start, respectively). Unopened vials stored under the same condi

SUBMITTER: Abdel-Tawab M 

PROVIDER: S-EPMC10895173 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature