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Comprehensive Bioconjugate Process Development for ADCs and Novel Conjugates

At Olon, we specialize in bioconjugate process development to help biotech and pharma innovators transform complex conjugates into safe, scalable, and regulatory-ready products. With over a decade of experience in conjugation technologies, and 40+ years of high-potent API manufacturing across the Olon network, we deliver solutions that span from early feasibility through to clinical and GMP production.

GMP quality control sterility testing for sterile injectables

Broad Capabilities Across Bioconjugates

At Olon, our team is proficient in supporting the development, optimisation, and scale-up of a wide variety of conjugation processes.

Leveraging both mammalian and microbial manufacturing for the production of biologic intermediates, we can design and execute processes for a diverse range of bioconjugates, including but not limited to:

    • Antibody-Drug Conjugates (ADC)

    • Antibody Fragment-Drug Conjugates (ScFvDC)

    • Antibody-Oligonucleotide Conjugates (AOC)

    • Protein- and Peptide-Drug Conjugates

This combination of scientific breadth and technical expertise enables us to adapt development strategies to each modality — from conventional ADCs to next-generation conjugates — while ensuring scalability, safety, and regulatory compliance.

Learn more about our antibody and protein manufacturing services

Mammalian or microbial manufacturing capabilities

Our expertise in both mammalian and microbial manufacturing allows us to provide solutions for the manufacturing of a wide range of bioconjugates.

Extended expertise in bioconjugation

For over a decade, our teams have been developing conjugation processes involving a variety of biomolecules (antibodies, proteins, peptides, antibody fragments, oligonucleotides…) and cytotoxic payloads.

Technical Expertise in Conjugation

Our teams combine single-use conjugation systems with robust analytical and purification tools to deliver processes that are efficient, reproducible, and safe.

    • Site-specific conjugations to ensure batch-to-batch consistency, high payload homogeneity, and thermal stability

    • Expertise in diverse linker chemistries (maleimide, engineered cysteine, enzymatic, cleavable/non-cleavable)

    • Experience with multiple payload classes: small molecules, toxins, oligonucleotides, radionuclides

    • Scalable conjugation: from microgram development through to gram and clinical-scale GMP batches

    • Downstream recovery: high-containment chromatography, TFF for payload clearance

    • Analytical package including DAR determination, intact mass, peptide mapping, glycan analysis, stability testing

Fill and finish of viscous gels and complex biologics

Streamline your ADC production with our comprehensive development & manufacturing services

With our unmatched expertise and capabilities, we seamlessly cover every stage of your antibody drug conjugate project, from antibody intermediate production to bioconjugation and GMP manufacturing of drug substance and drug product.

Integrated Development and GMP Transition

GTP Bioways CDMO - Cell line development for Bioconjugates

Bioconjugate development at Olon is engineered for regulatory alignment and smooth GMP transfer:

    • Development using scale-down GMP models to anticipate production behavior

    • Conjugation suites designed for high containment and operator safety

    • Integration with Olon Italy’s OEB6-certified Rodano facility for payload and linker manufacturing (OEL down to 10 ng/m³)

    • Dedicated QA/QC oversight ensuring compliance with EMA, FDA, and ICH requirements

This combination ensures your program can move confidently from R&D to clinical production.

Why Choose Olon for Bioconjugate Development?

Integrated platform – conjugation, analytics, GMP manufacturing, and regulatory support

Dual expression systems – mammalian & microbial intermediates for maximum flexibility

Containment expertise – OEB6-certified facilities for ultra-potent payloads and linkers

Broad scope – ADCs, ScFvDCs, AOCs, peptides, proteins

Proven partner – 10+ years of ADC experience, 40 years of HPAPI expertise, and global biotech partnerships

Frequently Asked Questions (FAQ)

What types of bioconjugates does Olon develop?

We support ADCs, ScFvDCs, AOCs, and peptide/protein-drug conjugates, backed by both mammalian and microbial expression platforms.

Do you provide site-specific conjugation services?

Yes. We offer site-specific conjugation strategies to ensure consistency, payload homogeneity, and stability.

What scales of conjugation can you support?

We develop conjugates from µg–mg scale for feasibility, up to hundreds of grams for clinical GMP batches.

How does Olon ensure regulatory compliance?

All processes align with EMA/FDA/ICH guidelines, with integrated QA/QC oversight and CMC documentation for IND/IMPD submissions.

Can Olon manufacture payloads and linkers?

Yes. At our Rodano (Italy) OEB6 facility, we produce ultra-potent payloads and linkers under strict containment (OEL down to 10 ng/m³).

Which analytical methods are available for conjugates?

We provide a full analytical package, including DAR determination, intact mass, peptide mapping, glycan analysis, cytotoxicity bioassays, and stability studies.

Expert team in downstream process development