Download: Technical Note - Compatibility Assessment of a Model Monoclonal Antibody Formulation
Using BFS Technology to Enhance Delivery of Monoclonal Antibodie Formulations
Plastic vials produced via blow-fill-seal (BFS) technology can reduce problems associated with glass such as protein-surface interactions, vial breakage and glass delamination. Additionally, BFS can enable flexible primary container designs and
A comprehensive study was conducted to evaluate the impact of Woodstock Sterile Solutions’ optimized BFS filling process and ADVASEPT® container system on a model mAb formulation. . It evaluated protein potency, protein stability and leachables in glass and in ADVASEPT® vials over long-term storage under refrigerated conditions (5°C). Results indicate that the mAb’s stability was comparable in both primary container systems. Download this paper to learn more.