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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...
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| Main Authors: | , , , |
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| Format: | Artigo |
| Language: | Inglês |
| Published: |
Springer US
2011
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| Subjects: | |
| Online Access: | 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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