Protein Engineering
Fc engineering closely links to therapeutic antibodies properties. Here at Creative Biolabs, we propose CDC⁺ antibody technology that can increase IgG affinity for C1q by more than 100-fold. This is done by engineering on Fc portion, and thereby, increasing CDC performance. In order to achieve accurate Fc engineering modification, we have developed a variety of targeted gene editing tools to effectively screen mutants from glycosylation.
Protein engineering mainly focus on the following aspects:
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Crea-Tag™ and antibody fusion protein engineering
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Fc region site-specific variants engineering
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IgG cross-subtype (IgG1&IgG3) engineering
Targeted gene-editing tool
It is quite a challenge to select various glycosylation mutants from the gene copy of same carbohydrate derivatives. We have developed diverse gene-editing tools that can perform non-lethal knockout by targeting on a single or a set of genes.
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Transcriptional activator-like effector nuclease (TALEN)
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CRISPR-Cas9
Cell Line Development
Creative Biolabs provides mammalian cell lines for the production of recombinant therapeutic proteins that produce a large number of consistent quality products to meet regulatory requirements.
Fc protein-engineering host cell lines
Based on our advanced gene manipulation technology, we offer our customers with Fc-engineered cell lines. Our optimal Fc-engineering host cell line has several advantages:
i. Excellent Fc ability
ii. Preventing the synthesis of unfavorable Fc mutations
iii. Possibility to produce optimized Fc variants
These properties are highly desirable for the production of bio-better versions of therapeutic CDC⁺ proteins.
Cell line development workflow
For more details, please click Sable cell line service. 
Bioprocess Control
Like other biopharmaceuticals, therapeutic CDC⁺ antibodies also require extremely high purity and potency. Creative Biolabs monitors parameters from Quality by Design (QbD) and Critical Quality Attribute (CQA) throughout the production. For the upstream biological process, QbD is adopted to make sure manufacturing activity and product quality are defined during the designing stage of project development. The key to implementing QbD is to pinpoint CQA. We have established systematic approaches to identifying and ranking CQAs through safety and effectiveness (SE) analysis and the construction of impact maps.
Fig.1 Implementation of QbD approach for the production of therapeutic drugs.1,2
Purification Strategies
Like other biopharmaceuticals, CDC antibodies require excellent purity and constant potency in order to work in maximum efficiently. For this reason, achieving efficient downstream purification is a critical step in the overall production process. For monoclonal antibody products, the industry standard for commercial scale purification is Protein A chromatography. While in the field of CDC antibody production, the capture step includes a unique affinity chromatography that can selectively capture the Fc variants.
CDC Analysis
Our experts have rich experience in related areas. They are able to help you define successful CDC characterization strategies to perform the required experiments. Our CDC analysis services include:
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C1q binding analysis
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FACS binding analysis of antibodies and target cells
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Functional cell-based cell death analysis
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Analytical appraisal report applicable to regulatory requirements.
For more details, please click Therapeutic CDC⁺ Antibody Analysis.
With decades of experience in the field of antibody development, Creative Biolabs is able to provide our clients with the flexibility to adapt evolutionary changes in CDC⁺ antibody development field. For more details about our Therapeutic CDC⁺ Biobetter Antibody Production service, please do not hesitate to contact us.
References
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Gupta, Sanjeev K., and Pratyoosh Shukla. "Sophisticated cloning, fermentation, and purification technologies for an enhanced therapeutic protein production: a review." Frontiers in pharmacology 8 (2017): 419.
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under Open Access License CC BY 4.0, without modification.
