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Front-loading biosimilar development with analytical characterization

Published in: Volume 11 / Year 2022 / Issue 2
Page: 82-4

Abstract: An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and… Read More »

Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated

Published in: Volume 11 / Year 2022 / Issue 1
Author(s):
Page: 41-4

Abstract: Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have… Read More »

Next generation processing of monoclonal antibodies

Published in: Volume 6 / Year 2017 / Issue 1
Author(s): , ,

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Sourcing innovator products in the age of biosimilar research

Published in: Volume 4 / Year 2015 / Issue 2
Author(s):

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Biosimilar monoclonal antibodies development simplified

Published in: Volume 3 / Year 2014 / Issue 1
Author(s):

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Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation

Author(s):

Abstract: Undoubtedly the complexity of Antibody Drug Conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with… Read More »

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