From DNA to cGMP: one trusted partner for monoclonal, bispecific, Fc-fusion, and ADC development & manufacturing.
Get a Free Project EvaluationAntibody programs can stall on cell line stability, weak upstream productivity, Protein A yields, charge variants, glycan profiles, or ADC conjugation consistency. Our end-to-end CDMO offering aligns CMC strategy with your clinical goals—integrating cell line development, QbD-driven process optimization, phase-appropriate analytics, and cGMP manufacturing to deliver right-first-time results.
We solve key program pains:
End-to-end coverage from DNA design through clinical/commercial supply, including ADC conjugation and aseptic fill/finish.
Transparent, phase-gated milestones to ensure tech-transferability and regulatory readiness—from DNA to PPQ.
Initial discussion on your antibody, goals, and regulations.
Generate/optimize stable, high-yield cell lines for robust expression.
Optimize cell culture, bioreactor parameters to maximize quality at scale.
Develop efficient purification for high purity/recovery.
Produce antibody under manufacturing practice for clinical/commercial supply.
Initial discussion on your antibody, goals, and regulations.
Generate/optimize stable, high-yield cell lines for robust expression.
Optimize cell culture, bioreactor parameters to maximize quality at scale.
Develop efficient purification for high purity/recovery.
Produce antibody under manufacturing practice for clinical/commercial supply.
| Stage | Services | Key Technologies & Readouts |
|---|---|---|
| Project Consultation & Design | Initial discussion on antibody goals and regulations. DNA design, codon optimization, vector selection (GS/DHFR), and developability assessment. | Sequence liability review; Fc engineering; regulatory strategy planning. |
| Cell Line Development | Generate and optimize stable, high-yield cell lines (CHO/HEK) for robust expression. Clone screening & banking (MCB/WCB). | High-throughput screening (titer, quality); glycan/charge variant profiling; monoclonality assurance. |
| Upstream Process Dev | Optimize cell culture and bioreactor parameters. Fed-batch/perfusion process dev; media/feed optimization. | QbD/DoE; PAT; scale-down models; seamless scale-up to 2,000 L. |
| Downstream Process Dev | Develop efficient purification for high purity/recovery. Protein A capture, viral inactivation, and polishing steps (e.g., IEC, HIC). | Impurity clearance validation (HCP/HCDNA); aggregation control; viral filtration; TFF. |
| Manufacturing Practice | Produce antibody under cGMP for clinical/commercial supply. Includes analytical method qualification, formulation, stability studies, and aseptic fill/finish. | cGMP up to 2,000 L; batch release & CoA; IND/IMPD support; PPQ runs. |
Purpose-built cell lines, process modes, and modalities to match your product’s CQAs and clinical strategy.
Industry-standard hosts optimized for productivity and human-like PTMs.
Fed-batch for simplicity and perfusion for fragile or high-productivity molecules.
From classic IgG1 to complex formats and conjugates.
Phase-appropriate methods to support release, stability, and comparability.
Our platform supports a comprehensive range of engineered antibody formats, from simple fragments to complex multispecifics, including but not limited to those shown below.
A single-domain antibody (sdAb) derived from camelids, offering high stability and small size.
A fusion protein of the variable regions (VL and VH) connected by a flexible linker.
Two scFv fragments linked together, enabling simultaneous binding to two different targets.
A chimeric format combining the small size of a sdAb with the binding of an scFv.
A dimeric scFv format with short linkers, forcing non-covalent association of two chains.
A trimeric, non-covalent complex of scFv fragments, typically for trivalent binding.
A bivalent fragment (scFv) fused to a human IgG1 CH3 domain for dimerization.
The full-length heavy-chain-only antibody found in camelids, from which sdAbs are derived.
The 'Fragment, antigen-binding' region, consisting of one constant and one variable domain from each chain.
A single-chain Fab fragment where variable and constant domains are connected by linkers.
Two Fab fragments linked by disulfide bonds at the hinge region, creating a bivalent molecule.
An engineered F(ab)2 format capable of binding to two distinct target antigens.
A highly engineered format designed to bind three different targets simultaneously.
The 'Fragment, crystallizable' region, responsible for effector functions and half-life.
A bivalent format fusing an scFv to an Fc domain, mimicking a full antibody's structure.
A therapeutic protein created by fusing an Fc domain to a receptor, ligand, or peptide.
Explore our high-demand solutions for antibody discovery, development, and analysis.
High-throughput phage display antibody technology integrates genotype and phenotype and is capable of simulating the process of antibody production both in vivo and in vitro.
From gene sequence to hundreds of purified recombinant antibodies in as little as two weeks. Empower your screening, characterization, and lead optimization with unparalleled speed, scalability, and reliability.
Creative Biolabs offers a wide range of antibody-drug conjugates (ADCs) that can be produced, including monoclonal antibody-based ADCs, polyclonal antibody-based ADCs, and bispecific antibody-based ADCs.
Creative Biolabs offers a full range of capabilities to help customers solve ADC analysis problems. Development and validation of immunoassays, mass spectrometry-based methods, and cell-based assays for ADC quantification and functionality testing.
Creative Biolabs offers comprehensive bispecific antibody production services to support the development of novel therapeutics. Our experienced team of scientists can assist with the design, construction, expression, purification, and characterization.
Creative Biolabs offers a full range of antibody derivative development services, including antibody-lipid nanoparticle (LNP), antibody-extracellular vesicles (EVs), antibody-oligonucleotide conjugates, and antibody-coupled liposome development.
Our cGMP-aligned Quality Management System embeds QbD principles, data integrity (ALCOA+), and phase-appropriate controls across the lifecycle. Independent QA/QC oversight, validated analytical methods, and audit-ready documentation support smooth interactions with global agencies.
For antibodies and ADCs, we emphasize viral safety (inactivation/filtration), impurity control (HCP/HCDNA), and product-specific CQAs (glycans, charge variants, aggregates, DAR). We provide comprehensive regulatory documentation for IND/IMPD and scale with you through PPQ and commercial supply.
Biotech and pharma teams trust us for antibody and ADC programs from IND to PPQ.
“Creative Biolabs was instrumental in rescuing our difficult BsAb program. Their team quickly implemented a high-yield perfusion upstream process and developed a tailored polishing train. Most importantly, they successfully controlled the complex glycan and charge variants to meet our stringent specifications, allowing us to proceed with our IND filing on time.”
“We were impressed by the precision of their ADC team. They consistently nailed our target DAR of 3.5 and minimized free drug to well below our action limits. The final data package, including the comprehensive stability plan, was so thorough that it passed our internal QA review on the very first pass without any revisions.”
“The clear, proactive communication and their realistic, phase-appropriate approach were exactly what we needed. Their scientific team anticipated challenges and scaled seamlessly with us. We were able to move from pre-clinical tox batches directly into Phase 2 cGMP supply, all without the headache of changing CDMOs.”
Quick answers on platforms, timelines, analytics, and ADC specifics.
CHO is the industry standard for therapeutic antibodies, with GS or DHFR systems for stable expression. HEK293 can be used for rapid transient material or specific PTM needs. We evaluate desired CQAs (glycans, charge), timelines, and scale to recommend the best fit.
Yes. We handle knobs-into-holes, CrossMab, dual-variable domains, and Fc-fusions. Our upstream and polishing strategies address mispairing, aggregation, and variant control, supported by intact/subunit LC-MS and functional bioassays.
We apply platform and molecule-specific conjugation methods (site-specific or stochastic) with tight process windows. Analytics include DAR distribution, free drug, residual solvents/reagents, and potency. Formulation work mitigates aggregation and payload loss.
We design a phase-gated plan covering tox material, IND-enabling lots, and Phase 1 supply, with parallel method qualification and stability. A dedicated PM drives risk management and schedule integrity across workstreams.
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