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Manufacturability Assessment

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Creative Biolabs has established a manufacturability assessment platform for a full cascade of therapeutic antibody drug discovery and development, ranging from a series of approaches starting with a screening assay to developability assessment and optimization, covering humanization/deimmunization, immunogenicity assessment, epitope predicting and mapping, reengineering and manufacturability assessment.

Manufacturability Assessment Fig.1: Structure and antibody recognition of the HIV Envelope spike.

Manufacturability assessment consists of both productivity and stability assessment. Productivity is evaluated by which the product is manufactured with the correct structure and post-translational modifications at desired levels from a production cell line, purified in an intact form. During the production, some antibody drug candidates do not express or fold properly and some even cause extensive aggregation in the cell culture media or during the following purification procedures due to the structural modifications.

To address these issues that lead to potential clinical failure, Creative Biolabs, as a leading service supplier in the biotechnology and biopharmaceutical fields, offer comprehensive and state-of-the-art manufacturability assessment platforms for your target candidate including the following scopes:

Our platforms have already been widely utilized in a set of antibody products to avoid risks, reduce attrition and improve the quality and safety. Creative Biolabs also addresses the challenges and accelerates the design and evolution of promising antibody candidates. By screening antibody candidates in stable cell lines to evaluate their performance in the culture media, as well as in long-term storage, an outstanding candidate can be selected that abstains from these typical issues. These services offer you a complete portfolio for your drug discovery and early development in an efficient timeline.

Burton DR et al. Cell Host Microbe. 2012 Oct 18;12(4):396-407.

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