Therapeutic CDC⁺ Biobetter Antibody Production

Therapeutic CDC⁺ Biobetter Antibody Production

After your projects move to CDC optimization, let our therapeutic antibody development experts show you how to accelerate the development and unleash your CDC-enhanced antibody to an even greater potential. By the help of our specialists and their expertise in antibody production, as well as the state-of-the-art technology, we are committed to delivering our customers with the best antibody engineering service and ensuring every step during process meets your requirements.

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Quality

Promising on supreme antibody activity and purity, our scientists use their expertise in antibody expression and purification with state-of-the-art analytical techniques to meet the needs of our clients.

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Scale

Generating from our optimized protein expression system, we refine and create a stable cell line that has a high protein yield. Tools used include but are not limited to 96-well plates, shake flask fermentation, large bioreactors to scale-up purified proteins delivered from mammalian expression hosts.

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Customization

We have knowledge on end-to-end service development, ranging from DNA synthesis to protein production. If you’re ready to do the work in your lab, we're also happy to assist you on customized project.

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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:

  • Crea-Tag™ and antibody fusion protein engineering
  • Fc region site-specific variants engineering
  • 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.

  • Transcriptional activator-like effector nuclease (TALEN)
  • CRISPR-Cas9
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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

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For more details, please click Sable cell line service. arrow-blk-link.svg

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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.

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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.

Example purification strategies for “tricky” mAbsFig.1 Example purification strategies for “tricky” mAbs.

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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:

  • C1q binding analysis
  • FACS binding analysis of antibodies and target cells
  • Functional cell-based cell death analysis
  • Analytical appraisal report applicable to regulatory requirements.

For more details, please click Therapeutic CDC⁺ Antibody Analysis. arrow-blk-link.svg

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.

RESOURCES

Creative Biolabs provides luciferase-based ADCC assay. This Jurkat cell based assay is pioneered by Creative Biolabs, and the methodology is very well accepted by the field. See attached ADCC Reporter Assay Protocol for further details. 

All products and services are for Research Use Only. Do Not use in humans.

CASE STUDY

ADCC Assay WT vs AfucoTM Mabs  Visit

Resource

Antibody Fc Engineering: Towards Better Therapeutics  Visit

ONLINE INQUIRY

Creative Biolabs has established a team of customer support scientists ready to discuss ADCC/CDC optimization strategies, antibody production, bioinformatics analysis and other molecular biology/biotechnology issues.

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