Technical transfer and commercialisation of lyophilised biopharmaceuticals — application of lyophiliser characterisation and comparability
Abstract A holistic approach was taken to characterise lyophilisers at both laboratory and commercial scale to design a focused validation strategy for commercialising parenteral drug products. Vial heat transfer coefficients (Kv) and equipment mass transfer boundaries were generated for a Lyostar I...
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| Principais autores: | , , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
SpringerOpen
2022-09-01
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| coleção: | AAPS Open |
| Assuntos: | |
| Acesso em linha: | https://doi.org/10.1186/s41120-022-00059-0 |
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