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Therapeutic Antibody Coding mRNA Development Service

Introduction Therapeutic Antibody-coding mRNA Workflow What We Can Offer FAQ

Introduction

Creative Biolabs' Therapeutic Antibody-coding mRNA Development Service is an innovative passive immunotherapy platform. It enables in vivo antibody production via the body's cells, bypassing ex vivo manufacturing and retaining natural biological fidelity, offering a scalable, rapid alternative to traditional protein infusions. With advanced mRNA design, optimized LNP delivery, and in vivo expression platforms, we accelerate drug discovery, reduce manufacturing costs by up to 1,000-fold, lower systemic toxicity, and deliver refined constructs for preclinical and clinical use.

Creative Biolabs specializes in developing therapeutic candidates that harness the high efficiency and transient nature of the mRNA platform.

Therapeutic Antibody-coding mRNA Development Service

Therapeutic Antibody-coding

We provide design and optimization services for a full spectrum of antibody formats, maximizing their therapeutic potential while minimizing safety risks:

  • Full-Length Immunoglobulin G (IgG): Co-delivery of heavy and light chain mRNA for conventional passive immunity.
  • Bispecific and Multi-Specific Antibodies: Engineering complex, multi-chain formats like Bispecific T-Cell Engagers (TCEs) and Bispecific Costimulatory antibodies, often utilizing Fc-free or Fc-silent domains to eliminate systemic toxicity inherent to traditional FcγR binding.
  • Single-Chain Antibodies (scFv) and single-domain antibodies (sdAbs): Optimization for smaller, highly penetrant formats capable of targeting intracellular proteins and other targets inaccessible to larger IgGs.
  • Half-Life Extended Fusions: Integration of fusion elements, such as engineered human serum albumin variants, directly into the mRNA sequence to provide programmable Pharmacokinetic (PK) profiles and sustain therapeutic levels for specific durations.

Schematic diagrams of mRNA and antibody designs used in recent studies. (OA Literature) Fig.1 The design diagrams of mRNA and antibodies currently used in the research include the basic structure of the constructs, possible different forms of mRNA, and other contents.1,3

Key Advantages

  • Massive Cost Reduction: Compared to recombinant protein production, significantly lower the cost of goods sold (COGS), improving therapeutic antibody accessibility and scalability for your project.
  • Biological Fidelity: In vivo translation ensures antibodies have natural folding and correct human glycosylation patterns, potentially enhancing functional activity and reducing immunogenicity.
  • Accelerated Timelines: Bypass cell line development and fermentation steps, enabling rapid transition from sequence design to in vivo functional validation within weeks to shorten your project cycle.
  • Enhanced Safety Profile: Support design of Fc-free/silent antibody formats, eliminating severe systemic off-target toxicities (e.g., complement activation, liver damage) associated with some advanced agonistic antibodies.

Applications

  • Passive Immunization: Rapid, on-demand provision of neutralizing antibodies for infectious diseases (e.g., seasonal viruses, emerging pathogens).
  • Cancer Immunotherapy: Delivery of highly potent agents, including bispecific T-Cell Engagers (TCEs) and 4-1BB costimulatory antibodies, with localized and safer activation to treat solid tumors.
  • Chronic Disease Treatment: Sustained, transient expression of neutralizing or anti-inflammatory antibodies for diseases requiring periodic dosing.

Workflow

Our robust workflow is designed to provide clear, milestone-driven progress, assuring optimal antibody expression and safety profiling for your therapeutic candidate.

Required Starting Materials

  • Target Sequence/Antigen Data: Detailed information on the target antigen, including species reactivity and desired binding affinity.
  • Desired Antibody Format: Specification of the therapeutic format (e.g., full-length IgG, scFv, Bispecific T-Cell Engager).
  • Targeted Expression Profile: Requirements for antibody half-life (e.g., transient vs. prolonged expression) and preferred delivery route.
Consultation & Design
mRNA Design

mRNA Design and Optimization

Engineer synthetic mRNA sequences with N1-methylpseudouridine, optimized Cap1, UTRs, and mammalian cell-targeted codon optimization to boost translational efficiency, stability, and obtain high-purity, low-immunogenicity transcripts.

In Vitro Transcription (IVT) and Purification

Perform high-quality IVT for optimized mRNA, apply stringent purification to remove dsRNA byproducts and contaminants, ensuring lot-to-lot consistency and stability.

IVT & Purification
LNP Formulation

LNP Formulation and Delivery Strategy

Encapsulate purified mRNA into optimized LNPs, targeting the liver for expression and offering rational LNP designs for alternative biodistribution, like local or systemic lung delivery.

In Vitro Functional Validation

Test mRNA-LNP complexes in cell cultures to confirm antibody translation, folding, secretion, antigen-binding specificity, and in vitro activity vs recombinant protein benchmarks.

Functional Validation
In Vivo PK/PD

In Vivo PK/PD Analysis

Evaluate final constructs in preclinical models, tracking mRNA-LNP biodistribution, antibody expression kinetics, and correlating mRNA dose with therapeutic dose.

Final Deliverables

  • Optimized mRNA/LNP Construct: Ready-to-use formulation of the purified therapeutic mRNA encapsulated in the validated LNP system.
  • Comprehensive PK/TK Report: Detailed data on mRNA biodistribution, antibody expression kinetics, and acute toxicity (toxicokinetics) in preclinical species.
  • Functional Antibody Expression Profile: Documentation validating the in vivo biological activity, folding, and natural glycosylation pattern of the endogenously produced antibody.
  • Estimated Timeframe: The typical timeframe for this service ranges from 12 to 20 weeks, depending on the complexity of the antibody format (e.g., full-length IgG vs. multi-chain bispecific) and the scope of the required in vivo PK/PD validation studies.
Final Deliverables

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Case Study

The mRNA for constructing bispecific antibodies: The entire structure contains 5' Cap: Cap1 and N1-me-Ψ. The mRNA template contains 5' UTR, Kozak sequence, 3' UTR, and poly(A) tail, as well as the target coding sequence. The mRNA was transfected into HEK293 cells, and the bands of the expected molecular weight were detected from the supernatant by Western Blot assay. In addition, the specific binding of the target RNA to hEGFR was confirmed by ELISA experiments. Flow cytometry showed that the target RNA could bind to CD3 on mouse 2B4 T cells and EGFR on human CT26 EGFR cells, and had the ability to stimulate INF-γ.

Functional characterization of mRNA-encoded bispecific antibodies. (OA Literature)Fig.2 Functional detection of mRNA-encoded bispecific antibodies.2,3

Customer Reviews

  • [Faster Kinetics] "Using Creative Biolabs' Therapeutic Antibody-coding mRNA Development Service in our research has significantly improved the speed at which we validate novel neutralizing antibodies. The expression profile—detectable within 2 hours and peaking at 24 hours—allows us to complete PK screening cycles that previously took weeks in just days."

    — Maria Torres, [5 months ago]

  • [Superior Format Versatility] "The ability to efficiently encode multi-chain Fc-free bispecific antibodies was a game-changer. This approach directly addresses the off-target toxicity issues we encountered with recombinant 4-1BB agonists, allowing us to safely enhance T-cell activity while eliminating the FcγR-mediated cross-linking responsible for liver toxicity. This is a crucial safety advantage."

    — Jessica Bennett, [2 weeks ago]

  • [Unmatched Cost Efficiency] "We needed to scale production of an infectious disease passive immunization agent. The shift to mRNA has provided an unmatched cost advantage and allowed us to achieve circulating concentrations in vivo that were not economically feasible with traditional bioreactor production. The fidelity of the in vivo-produced antibody, with its natural glycosylation, is a huge bonus."

    — Daniel Foster, [1 year ago]

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FAQ

How does the cost and efficiency of the mRNA platform compare to traditional recombinant antibody production?

The mRNA platform offers a profound cost advantage, with the potential to reduce manufacturing costs by orders of magnitude (e.g., from tens of thousands of dollars to approximately $100 per dose). Furthermore, published data indicate that a low dose of an optimized mRNA-LNP can often achieve a significantly higher circulating antibody concentration in vivo than a much larger dose of recombinant protein, improving overall efficiency.

Can Creative Biolabs' service accommodate complex antibody formats like Bispecifics?

Absolutely. Our platform is optimized to encode and express a wide range of complex formats, including single-chain variable fragments (scFv) and multi-chain Bispecific T-Cell Engagers (TCEs). We specifically utilize this platform to design Fc-free versions of these potent molecules to ensure targeted activity and minimize systemic side effects.

What measures do you take to prevent the mRNA from causing an adverse immune response or immunogenicity in vivo?

We employ state-of-the-art engineering techniques, including the use of N1-methylpseudouridine (N1-me-Ψ) modified nucleosides to mask the mRNA from innate immune sensors (like TLRs), resulting in lower immunogenicity and higher translational yield. We also ensure rigorous purification protocols to remove immunogenic double-stranded RNA contaminants.

How long does the therapeutic antibody expression typically last after a single administration of the mRNA-LNP?

Antibody expression is designed to be transient. Peak expression typically occurs within 24 to 48 hours post-administration, with expression generally lasting for several days to over a week, depending on the mRNA design and the use of half-life extension fusion elements. This duration can be precisely controlled by our custom design strategies.

Is the therapeutic effect limited to liver expression, or can you target other organs?

While the current generation of LNPs primarily targets the liver, Creative Biolabs is actively engaged in LNP engineering to achieve diverse biodistribution. We offer custom LNP formulations and modification strategies to explore localized delivery or target specific non-hepatic organs, such as the lungs or tumor microenvironment, depending on your clinical indication.

Creative Biolabs is committed to pioneering the next wave of antibody therapeutics through our specialized Therapeutic Antibody-coding mRNA Development Service. By combining unprecedented cost efficiency with high biological fidelity and advanced format engineering, we provide a pathway to rapidly deliver high-impact therapeutic candidates.

Contact Our Team for More Information and to Discuss Your Project

Hot IVT Vectors

Cat. No Product Name Promoter
GTVCR-WQ70MR IVTScrip™ pSP6-VEE-mRNA-Anti-ALB&IL6R, 20A11-9mer-ALB11 Vector SP6
GTVCR-WQ71MR IVTScrip™ pT7-VEE-mRNA-Anti-TYRP1, 20D7S Vector T7
GTVCR-WQ73MR IVTScrip™ pSP6-VEE-mRNA-Anti-TYRP1, 20D7S Vector SP6
GTVCR-WQ76MR IVTScrip™ pT7-VEE-mRNA-Anti-ANGPT2, 2xCon4C Vector T7
GTVCR-WQ78MR IVTScrip™ pSP6-VEE-mRNA-Anti-ANGPT2, 2xCon4C Vector SP6

Hot IVTScrip™ mRNA Transcript

Cat. No Product Name Type
GTTS-WQ40MR IVTScrip™ mRNA-Anti-TNFRSF17, 2857916(Cap 0, Pseudo-UTP, 30 nt-poly(A)) Antibody
GTTS-WQ41MR IVTScrip™ mRNA-Anti-TNFRSF17, 2857916(Cap 1, Pseudo-UTP, 30 nt-poly(A)) Antibody
GTTS-WQ42MR IVTScrip™ mRNA-Anti-TNFRSF17, 2857916(Cap 1, Pseudo-UTP, 120 nt-poly(A)) Antibody
GTTS-WQ43MR IVTScrip™ mRNA-Anti-TNFRSF17, 2857916(Cap 0, N1-Methylpseudo-UTP, 120 nt-poly(A)) Antibody
GTTS-WQ44MR IVTScrip™ mRNA-Anti-TNFRSF17, 2857916(Cap 1, N1-Methylpseudo-UTP, 120 nt-poly(A)) Antibody

References

  1. Deal, Cailin E., Andrea Carfi, and Obadiah J. Plante. "Advancements in mRNA encoded antibodies for passive immunotherapy." Vaccines 9.2 (2021): 108. https://doi.org/10.3390/vaccines9020108.
  2. Hangiu, Oana, et al. "Effective cancer immunotherapy combining mRNA-encoded bispecific antibodies that induce polyclonal T cell engagement and PD-L1-dependent 4-1BB costimulation." Frontiers in Immunology 15 (2025): 1494206. https://doi.org/10.3389/fimmu.2024.1494206.
  3. Distributed under Open Access license CC BY 4.0, without modification.
All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.