Process Development Service
Creative Biolabs offers unique and unrivaled expertise in the research, development, validation, and multi-gram manufacture of therapeutic antibodies and proteins. Our scientific knowledge provides the full process of the mAb project from early Purification Development to successful manufacturing.
Streamlined Antibody Development from Discovery to Clinic Service
Over the decades, the therapeutic antibody has been successfully introduced into drug libraries for treating patients, with fierce innovation in antibody production and engineering. Antibody engineering involves the introduction of antibody binding sites (variable regions) into a series of structures that further influence treatment characteristics, thus achieving further advantages and success in patient treatment. Our experienced team can effectively shorten the clinical batch time of the monoclonal antibody development project. The service modules we provide cover the whole process from antibody discovery to development and optimization.
We invite you to confidentially explore a potential partnership with us - Request a consultation.
Fig.1 Structural model of a human IgG1.1
What We Can Offer
Creative Biolabs provides custom selection conditions to achieve the highest specificity and to address complex issues such as difficult target antigens or human/rat cross-reactions. We provide the following antibody customization services, but not limited to these:
| • ScFv | • Fab | • VHH | • IgG |
Based on our comprehensive range of capabilities, we can meet all of your mAb process development requirements:
We offer an efficient transient transfection platform: HEK and CHO cells, ideal for proof-of-concept and antibody screening programs.
We provide comprehensive monoclonal and polyclonal antibody development services in the fields of antigen design, peptide synthesis, and recombinant protein production.
We offer a search service for the sequence or accession number of the protein and the best possible epitope for antibody generation.
Our antibody process development service fits customer demands for fast-track process development.
How Creative Biolabs' service Can Assist Your Projects
Highlights
Integrated QbD from Day One
Our strict adherence to quality by design (QbD) principles ensures robust process alignment, eliminating costly rework during later validation phases.
Cutting-Edge High-Throughput Technology
We utilize advanced systems, including the Ambr series for micro-scale bioreactor screening and JMP software for sophisticated design of experiments (DoE).
Expertise in Complex Modalities
We specialize not only in platform mAbs but also in challenging next-generation therapeutics (bispecifics, complex viral vectors) where purification challenges are greatest.
High-Concentration Formulation Capability
Our specialized platforms deliver high-titer, low-viscosity formulations (up to 150 mg/mL) critical for improving delivery via convenient subcutaneous injection.
Let us commence our collaboration under a nondisclosure agreement - Get a quote today.
Customer Reviews
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Robust Yield Control
Using Creative Biolabs' process development service in our research has significantly improved the predictability of our upstream fermentation runs. The DoE strategy identified a clear, proven acceptable range for pH, which eliminated batch-to-batch variability we were struggling with previously, making our tech transfer seamless. - Dr. Li***. -
Efficient Impurity Clearance
The implementation of pH-gradient cation exchange chromatography suggested by Creative Biolabs dramatically enhanced the removal of product-related impurities from our bispecific antibody. This strategic refinement allowed us to hit a 99.5% purity target, a significant improvement over our previous platform. - Dr. Ch***ng.
FAQs
Is your process development service suitable for non-standard molecules, like antibody fragments?
Absolutely. While we have robust platform processes for standard mAbs, our expertise and screening capabilities are specifically designed to address the unique challenges of complex modalities, including scFv and Fc fusion proteins. We tailor the purification train, often leveraging specialized chromatography media, to ensure efficient clearance for these non-platform molecules.
How does Creative Biolabs ensure the process will be accepted by global quality system auditors?
Our entire PD methodology is built upon QbD principles. This means we don't just find a working process; we define the entire operating space, characterize all critical process parameters, and establish the control strategy required by auditors. All documentation is prepared to seamlessly support your process documentation, audits, and technology transfer.
How to Contact Us
Tell us what you need, and we will provide a guide to project cost estimates and timelines as soon as possible so that you can plan your next steps after the service is completed. Contact us or send us a query directly.
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Reference
- Chiu, Mark L, and Gary L Gilliland. "Engineering antibody therapeutics." Current opinion in structural biology vol. 38 (2016): 163-73. Distributed under an Open Access license CC BY 4.0, without modification. https://doi.org/10.1016/j.sbi.2016.07.012
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