The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics
Volume: 110, Issue: 3, Pages: 1025 - 1041
Published: Mar 1, 2021
Abstract
The pharmaceutical industry has experienced great successes with protein therapeutics in the last two decades and with novel modalities, including cell therapies and gene therapies, more recently. Biotherapeutics are complex in structure and present challenges for discovery, development, regulatory, and life cycle management. Biotherapeutics can interact with the immune system that may lead to undesired immunological responses, including...
Paper Details
Title
The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics
Published Date
Mar 1, 2021
Volume
110
Issue
3
Pages
1025 - 1041
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