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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Bibliographic Details
Main Authors: Sean Cullen (Author), Emma Walsh (Author), Valeria Gervasi (Author), Dikshitkumar Khamar (Author), Timothy R. McCoy (Author)
Format: Book
Published: SpringerOpen, 2022-09-01T00:00:00Z.
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3rd Floor Main Library

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Call Number: A1234.567
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