Antibody-Oligonucleotide Conjugate (AOC) Manufacturing

GMP precision for next-generation oligo therapeutics.

Developing and manufacturing antibody-oligonucleotide conjugates (AOCs) demands precision and expertise. At Abzena, we apply our proven bioconjugation platform to deliver phase-appropriate AOC manufacturing across our U.S. cGMP facilities.

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AOCs combine the specificity of monoclonal antibodies with the gene-modulating potential of oligonucleotide payloads (e.g., siRNA, ASO) through site-specific chemistries, overcoming the cell-penetration and biodistribution limitations of naked oligos and enabling delivery to a broader range of tissues.

Our fully integrated workflow spans regulatory strategy, antibody supply, GMP oligo synthesis partnerships, conjugation, multi-mode purification, and rigorous release/stability testing. Real-time analytics control the oligo-antibody ratio, minimize free oligo/antibody and impurity profiles, and support scalability from preclinical through to commercial supply.

AOCs Scale-up from R&D to the Clinic

Bioconjugate Development

Transitioning AOCs from R&D to preclinical development and manufacturing introduces some distinct challenges.

With over 20 years of experience working with the most complex large molecules, Abzena has the conjugation and manufacturing expertise to support your AOC manufacturing project.

For downstream success, this requires:

  • Expanding manufacturing capabilities to support larger-scale production
  • Developing and validating analytical methods to meet regulatory expectations
  • Assembling GMP documentation to meet increasing regulatory requirements, even in Phase I

End-to-end Workflow

Stage What we deliver Technical focus
Antibody supply AbZelectPRO™ cell-line creation, fed-batch upstream & downstream purification, or tech-transfer of client lines GMP antibody or fragments ready for conjugation in alignment with ICH Q5A-D, ICH Q6, ICH Q7, ICH Q11
QC GMP synthesis via qualified partners; incoming ID, purity, and impurity testing in-house siRNA/ASO payloads that meet EMA/CHMP/CVMP/QWP/262313, ICH Q6, ICH Q7, ICH Q11
Conjugation Coupling methods: maleimide-thiol (cysteine), NHS-ester, copper-free click (DBCO/azide), enzymatic conjugation and Abzena’s proprietary ThioBridge® site-specific chemistry.

Chemical linkers: cleavable and non-cleavable design, tuned for plasma stability and controlled release, including proprietary meleimide-based and click-chemistry linkers

Specification setting, starting and intermediate characterization, free oligo, free antibody, low aggregates, high recovery, diastereomer characterization, strand hybridization, annealing alignment
Purification Resin capture/polish, tangential-flow filtration, viral clearance where required Efficient removal of free oligo, conjugate variants, impurity removal
BDS Fill and disposition Liquid or lyophilized formulation, aseptic filling, release, disposition DP partner shipment-ready presentation
Release & stability Documented release, safety and stability testing, BSE/TSE certification, certified disposition documentation Confirms identity, purity, potency, and safety of DS
Regulatory support Regulatory filing leaflet authoring, gap/risk/comparability assessments, strategic and product specific guidance/planning ICH M4Q compliant documentation (characterization and control of drug substance, reference materials, stability and container closure) asset regulatory and development strategy

Facility & Quality Highlights

Bioconjugate & ADC Analytical Method Development - Abzena

  • Modular single-use consumables minimize cross-contamination
  • Optimized process step unit operations for diverse oligonucleotide constructs
  • LabZient™ real-time analytics tracking critical quality attributes (CQAs) during every batch

Regulatory Support for AOCs

Bioconjugate & ADC Commercial Manufacturing - Abzena

Regulatory expectations for AOCs are evolving and incomplete. The unique characteristics of AOCs – particularly their oligo payloads – present challenges that existing frameworks do not currently and fully address. This means the implementation of prior knowledge and platform manufacturing strategies to expedite development programs can be difficult. To overcome this, leading complex bioconjugate developers like Abzena adopt proactive and scientifically rigorous approaches, including partnering with experienced suppliers and consultants, and global regulatory bodies.

On-Demand Webinar: Solving the AOC Puzzle

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Access our on-demand webinar ‘Solving the AOC Puzzle: Strategies for chemistry, manufacturing and regulatory success’ to explore how we can meet the challenges manufacturing AOCs.

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Why choose Abzena for manufacturing AOCs?

  • Every step, from antibody production to oligo supply, conjugation, runs within a single, harmonized quality system, eliminating risky tech transfers and keeping timelines tight.
  • Decades of bioconjugation work and regulatory expertise, refined across hundreds of antibody-drug conjugate (ADC) and other bioconjugate programs, translate directly into AOC-specific technical depth.
  • Our versatile linker options allow scientists to tune plasma stability and intracellular release for each target, while a single global documentation set, spanning pre-clinical to commercial supply, streamlines regulatory review.
  • Scalable, optimized process development expertise from lab-scale to GMP supply that draws on our integrated facilities and platform technologies to save development time and reduce costs.
  • Proactive CMC planning and product-specific regulatory guidance from in-house experts who surface risks early and with complete, phase-appropriate data, keep AOC projects product-specific and inspection-ready.
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On-Demand Webinar: Solving the AOC Puzzle - Strategies for chemistry, manufacturing and regulatory success

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On-Demand Webinar: De-Risking Early Development Strategies for AOCs

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Cell Line Development

AbZelectPRO™, our cell line development platform, yields gram-per-liter antibody titers for large AOC campaigns.

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Analytical Method Development & Validation

Reliable analytical methods to characterize your bioconjugate product, generating the critical data needed.

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What are your drug development goals? - Abzena

Move your AOC forward.

From oligonucleotide API development to GMP conjugation, Abzena aligns every discipline you need to transform ambitious oligo therapeutics into clinic-ready AOCs.

Contact us to discuss your oligo development goals today.

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