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Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches

A monoclonal antibody (mAb) product development case study is presented to address some of the issues faced during developing a pre-filled syringe (PFS) product for a biotherapeutic. In particular, issues involving incompatibility with silicone oil and a stability-based approach for selection of PFS...

תיאור מלא

שמור ב:
מידע ביבליוגרפי
Main Authors: Badkar, Advait, Wolf, Amanda, Bohack, Leigh, Kolhe, Parag
פורמט: Artigo
שפה:Inglês
יצא לאור: Springer US 2011
נושאים:
גישה מקוונת:https://ncbi.nlm.nih.gov/pmc/articles/PMC3134644/
https://ncbi.nlm.nih.gov/pubmed/21538214
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-011-9617-y
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