Services / XDC

We know ADC and XDC. From synthesis to signal.

End-to-end expertise across antibody-drug conjugate (ADC) and broader any drug conjugate (XDC) development, from highly potent payload and linker chemistry through bioconjugation, fill-finish and GLP bioanalysis.

Advancing Complex Biotherapeutics

One coordinated platform for ADC and XDC programs

Antibody-drug conjugates (ADCs) and the wider family of “any drug conjugate” (XDC) modalities pair the targeting selectivity of antibodies and other biologic carriers with the therapeutic strength of small molecules. XDC formats now extend well beyond classical ADCs to include polymer-drug, oligo-drug and nanoparticle-drug conjugates.

Developing and manufacturing these biotherapeutics demands tight integration between chemistry, biology and analytics. Ardena’s coordinated platform brings together drug linker and payload synthesis, bioconjugation chemistry, purification and bioanalytical testing inside a single quality and regulatory framework — with GMP high-containment capabilities, advanced bioanalytical expertise, and data packages built to meet regulatory expectations.

01 Drug Linker and Payload

Drug Linker and Payload

We develop and manufacture highly potent payloads and drug linkers, combining deep small-molecule chemistry expertise with strict containment and quality control. Our linker chemistry portfolio covers enzymatically cleavable and click chemistry approaches — supporting the design of stable, well-controlled conjugates that release the payload where it is needed.

Key capabilities

  • Safe handling of OEB5 compounds (OEL >0.1 µg/m³ < 1 µg/m³) and readiness for OEB6 (OEL >0.01 µg/m³ < 0.1 µg/m³) operations by 2026
  • Expertise in enzymatically cleavable and click chemistry linkers
  • Preparative HPLC purification using LC200 systems
  • GMP compliant synthesis and analytical release testing
  • Very broad range of organic chemistry expertise
02 Bioconjugation

Bioconjugation Chemistry

We performs precise, scalable conjugation of antibodies, proteins, peptides and polymer systems with highly potent payloads under GMP conditions. The platform supports single and dual-payload constructs, including cytotoxic payloads and oligonucleotide payloads (AOCs), with bioconjugation carried out in Ardena’s precision-medicine cleanroom.

Process design focuses on the parameters that matter most for conjugate quality: drug-to-antibody ratio (DAR), conjugation heterogeneity, yield and process robustness, with site-specific conjugation approaches available where program design requires it.

Technical highlights

  • Proven experience in antibody, polypeptide, polymer and nanoparticle conjugation
  • Process optimisation to control drug-to-antibody ratio (DAR), conjugation heterogeneity, yield and robustness
  • Tangential flow filtration (TFF) and chromatographic purification for removal of free payloads and catalysts
  • Scalable processes supporting volumes from laboratory to pilot production
  • GMP compliant synthesis and analytical release testing
03 Drug Product & Clinical Supply

Drug Product and Clinical Supply

We support GMP clinical manufacturing of ADCs and XDCs — ensuring controlled handling and fill-finish of complex conjugates. Our infrastructure and partner network enable secure, compliant, and temperature-controlled clinical supply across all development phases.

Capabilities

  • GMP clinical manufacturing of ADCs and XDCs
  • Aseptic fill-finish and lyophilisation
  • Stability studies and release testing
  • Packaging, labelling and cold chain logistics
04 Bioanalysis

GLP Bioanalysis and Biomarkers

Our bioanalytical service covers quantification of all ADC molecular entities — including total antibody, conjugated payload and free payload — together with immunogenicity and associated biomarker readouts. Ardena’s analytical labs are fully GLP compliant and support programs through preclinical and clinical phases.

Core competencies

  • Pharmacokinetics of total antibody, ADC, conjugated and free payload
  • Immunogenicity
  • Biomarker analyses: soluble, cellular and genomic biomarkers
  • Expertise in multiple modalities
05 CMC Regulatory

CMC Regulatory Support

ADC and XDC programs need CMC strategies that reflect the complexity of the conjugate — control of heterogeneity, potency, stability and analytical characterisation. Ardena prepares CMC documentation and regulatory-ready data packages aligned with clinical development needs and agency expectations in Europe and the US.

Support includes

  • CMC documentation to support regulatory submissions
  • Input on critical quality attributes and control strategies for conjugates
  • Technical writing support across chemistry, conjugation, manufacturing and bioanalysis
06 Emerging Modalities

Emerging Modalities

ADCs are one segment of a rapidly evolving conjugate field. Building on our work in linker chemistry, bioconjugation chemistry and bioanalysis, we support developers advancing next-generation XDC platforms.

Our experience extends to emerging conjugate formats including oligonucleotide conjugates, polymer-drug conjugates, nanoparticle-drug conjugates and Immune Stimulating Antibody Conjugates (ISACs). By combining drug linker chemistry, nanomedicine formulation and bioconjugation expertise, we help bring next-generation targeted therapies forward.

Let's collaborate

We know development™
Let's talk about yours

Your program has a specific set of challenges. Our scientists want to hear them. Get in touch and we'll set up a direct conversation with the right expert.

Direct contact

contact@ardena.com