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Bispecific antibodies (bispecifics) can simultaneously target two distinct antigens or epitopes, offering novel therapeutic strategies such as enhancing immune cell targeting of cancer cells or blocking multiple disease pathways. This dual specificity makes bispecifics effective in treating complex diseases, including certain cancers, autoimmune disorders, and eye conditions.1 As of 2024, 14 bispecifics have been FDA-approved, including blinatumomab (leukemia), emicizumab (hemophilia A), and faricimab (retinal diseases). The market is projected to grow from $11B in 2024 to $40B by 2030, driven by both conventional bispecifics and advancements such as antibody-drug and radioligand conjugates.2

Invenra has launched its Rapid Antibody Discovery Service, designed to simplify and de-risk the preclinical development of bispecific antibodies while reducing costs and enhancing downstream productivity. This service features an accelerated workflow for monoclonal antibody discovery, characterization, and selection, integrated with a combinatorial bispecific matrix strategy. Within just four months, this approach delivers fully characterized and optimized panels of bispecific leads. The resulting lead matrices identify the top-performing Fab arms and molecular configurations with proven developability as bispecifics, ready for preclinical evaluation and subsequent development.

Critical Elements of the Rapid Antibody Discovery Service

  • Engineered Phage Display Libraries: Synthetic libraries are key tools in antibody discovery, enabling rapid identification of high-quality leads through advanced design and selection strategies. Invenra’s libraries, created from over 500 million human sequences, apply data science, engineering, and molecular biology to replicate natural V(D)J recombination. This preserves native CDR-germline pairings, reducing immunogenicity and enhancing developability. Featuring over 10¹² sequences from clinically validated germlines and minimized CDR liabilities, these libraries produce binders optimized for rigorous preclinical testing and next-generation therapeutic development.
  • High-Throughput Robotic Workflow: An automated phage selection workflow has been designed to screen 30 unique libraries using three parallel selection protocols. Top leads are expressed and purified through a highly parallel, proprietary process. These leads undergo detailed characterization, including affinity measurement, kinetic analysis, sequence diversity evaluation, and cross-reactivity assessment, to identify the most promising candidates for progression to the matrix phase.
  • The B-Body® Bispecific Platform: The top candidates are expressed in a combinatorial matrix of over 250 permutations using Invenra’s B-Body Bispecific Platform. This high-yield platform facilitates one-step affinity purification of bispecifics, which are then assessed through multiple high-throughput functional gating assays. This process allows for the identification of a panel of leads, ready for advancement into preclinical studies.
Rapid Bispecific Antibody Discovery Workflow
Figure 1. Rapid Bispecific Antibody Discovery Workflow. This schematic outlines a four-step process to discover bispecific antibody leads in four months, rigorously qualifying candidates for affinity, cross-reactivity, developability, and yield. A matrix analysis evaluates binder configurations to identify the optimal Fab arm arrangements with therapeutic potential. See a more detailed version of the workflow.

Advantages of the B-Body Bispecific Platform

Invenra’s B-Body Bispecific Platform is a comprehensive solution for bispecific antibody development, integrating early discovery, small-scale transient expression for lead optimization, and engineered cell line production with yields of 6-11g/L for manufacturing—all within one platform. Its engineered IgG-like, low-immunogenicity backbone maximizes heterodimer yield, supports single-step purification with over 95% purity, and produces highly stable, ADC-compatible, non-aggregating bispecifics with low viscosity, even at 200mg/mL. The platform enables Fc modifications to enhance therapeutic efficacy and half-life.  With flexible antibody formats such as 1×1, 2×1, and 2×2 for expanded targeting, it is ideal for creating novel bispecific therapeutics for intravenous and subcutaneous administration.

Overview of the B-Body Platform for Accelerated Bispecific Discovery
Figure 2. Overview of the B-Body Platform for Accelerated Bispecific Discovery. The B-Body Platform simplifies bispecific antibody discovery by overcoming common production challenges. It enables high-yield expression and single-step purification of bispecific candidates, facilitating rapid evaluation. Designed for seamless transition from early discovery to cell line development and high-yield CMC, the platform offers scalability within an integrated system.

Accelerate Your Discoveries

The integration of Invenra’s B-Body Bispecific Platform with Rapid Bispecific Discovery can accelerate bispecific therapeutic programs by overcoming challenges with developability and stability. The matrix approach expands the pool of lead molecules considered for early preclinical evaluation, enhancing the likelihood of success. To learn more about how the Rapid Bispecific Antibody Discovery process can align with your therapeutic development needs, please contact Invenra.

 

References
1. www.biochempeg.com/article/252.html
2. www.globenewswire.com/news-release/2024/10/04/2958275/0/en/Global-Bispecific-Antibody-Market-Size-Bispecific-Antibodies-Sales-FDA-Approved-Bispecific-Antibodies-Market-Forecast.html

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