Experience.
Agility.
Antibody-Oligonucleotide Conjugate (AOC) Development by a Proven US-Based CDMO
As a premier US-based CDMO, GBI Bio Manufacturing is committed to providing high quality, high yield and cost-effective Antibody Oligonucleotide Conjugates (AOCs) to customer worldwide through advanced synthesis platforms and expertise. GBI has provided a single-source approach to maximize support for the process development, scale-up and manufacturing of AOCs.
AOCs belong to class of chimeric molecules whose structures combine two species of drug biomolecules including antibodies and oligonucleotides. The growing interest of AOCs in recent years stems from the antibody drug conjugates (and bio-conjugates) and oligonucleotides as therapeutic and diagnostic agents. AOCs represent an emerging class of functionalized antibodies that combine the specific binding ability of antibodies with the broad structural properties of oligonucleotide, thereby integrating the advantages of both antibodies and oligonucleotides.
Contact UsFull-Service Antibody-Oligonucleotide Conjugate Development
Our technical team excels in navigating the delicate balance of stability, affinity, and potency required for successful AOC programs. We focus on three critical pillars of development:
Structural Design: antibody manufacturing and activation, conjugation of preactivated oligonucleotide payload onto the antibody, AOC mole ratio, targeting and specificity. Expertise in site-specific, site-directed and random conjugation methods, including Click chemistry and specialized linkers to ensure optimal AOC mole ratio and maintain antibody binding affinity.
Integrated Analytical systems: Comprehensive characterization to confirm conjugate stability, binding affinity, and payload integrity throughout the scale-up process.
Scalable cGMP Manufacturing: Purpose-built facilities designed to manage the stringent handling requirements of both biologics and oligonucleotides.
20+ Years of Bioconjugation Expertise
A Legacy of Conjugation Excellence Since 2002, GBI has completed over 50 complex bioconjugation projects. We have successfully extended this deep-rooted expertise into the AOC landscape, guiding programs from initial proof-of-concept through process development, cGMP scale-up, and commercial manufacturing. Our development team understands the critical nuances that US companies rely on for complex oligonucleotide workflows.
DEA-Licensed Specialty Manufacturing GBI offers a unique regulatory advantage: as a DEA-licensed Schedule I and II manufacturer, we are uniquely equipped to develop and manufacture AOCs and bioconjugates involving controlled substances or highly potent payloads. This specialized infrastructure allows us to support pioneering programs—such as targeted oligonucleotide therapies for CNS disorders—delivering cGMP-compliant materials for every stage of preclinical and clinical study.
Our Bioconjugation Portfolio Includes:
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Targeted siRNA and ASO-Antibody Conjugates
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High-Potency Payload Conjugation (CNS & Oncology)
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Site-Specific Thio-ether and Click-Chemistry Linkages
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Radio-immunoconjugates and Fluorescent Labeling
Our development team understands the critical nuances of AOC optimization and scale-up—such as maintaining antibody affinity, charge-masking for improved PK/PD, and precise Drug-to-Antibody Ratio (DAR) control—making us a trusted CDMO US companies rely on for complex oligonucleotide conjugation workflows
Schedule I and II Controlled Substance Manufacturing
As a DEA-licensed Schedule I and II manufacturer, GBI is uniquely equipped to develop and manufacture AOCs and bioconjugates involving controlled substances or highly potent payloads. This specialized infrastructure allows us to support pioneering programs—such as targeted oligonucleotide therapies for CNS disorders—delivering cGMP-compliant materials for every stage from preclinical through clinical studies
We have selected GBI based on the years of experience they have in bioconjugation and in developing and manufacturing cADCs, radioimmunoconjugates, and other conjugates. They demonstrated a great deal of flexibility, worked within our budget, and delivered our ADC ahead of schedule.
Partner with a CDMO Built for Antibody-Oligonucleotide Conjugate Innovation
Whether you’re developing a theranostic radiopharmaceutical, vaccine conjugate, or next-generation bio-conjugates, GBI offers the technical depth, flexibility, and cGMP manufacturing infrastructure to scale your project from concept to clinic.
Contact us today to learn how our bioconjugation services can help bring your conjugated biologic molecule to life.
