Application of a single-use sterile transfer system in production process of human coagulation factor VIII

• DOI: 10.3760/cma.j.issn.1673-4211.2013.06.007
• Publication Date: 2013-12-10
• Authors: Yan Zheng
• Keywords: Coagulation system

Objective To evaluate feasibility for application of a single-use sterile transfer system (Allegro system) in production process human coagulation factor Ⅷ (FⅧ).Methods A based on Allegro was designed and validated.Allegro used FⅧ,and each qualitative indexes stability FⅧ were detected.Results Each validation result met regulatory requirements.Allegro had not an effect physical chemical properties products.The main extractable substances tert-butanol (＜ 3.0 mg/package) trimethylsilanol(＜4.5 mg/package).Both contents safety requirements.Each 3 batches prepared by using standards.Stability F products good.Conclusion The can be applied to FⅧ.

Key words: Factor Ⅷ; Technology,pharmaceutical; Validation studies; Single-use