We know Complex Chemistry
We work exclusively with the kind of molecules that keep other CDMOs up at night. PROTACs, molecular glues, drug-linker conjugates — some of the most scientifically demanding molecules in modern drug development, and some of the most important. Ardena has built the chemistry, the containment, and the expertise to develop and manufacture them from first gram to clinical supply.
Three modalities. One integrated platform.
Complex chemistry requires more than technical capability. It requires scientists who understand the full development context — from route scouting and stereochemistry control through to CMC regulatory submission. At Ardena, that expertise is built into every program.
Subject Matter Experts
Nanomedicine Facility
Ardena has expanded its capabilities with a new 2,200 m² nanomedicine facility at Pivot Park.
Ardena Oss
Ardena has expanded its capabilities with a new 2,200 m² nanomedicine facility at Pivot Park. Built to GMP Annex 1 standards, it features advanced cleanrooms, integrated development and analytical labs, and dedicated warehousing. This investment strengthens our end-to-end support for precision medicine, meeting growing demand for high-quality, scalable nanomedicine solutions.
View Facility DetailsTargeted protein degradation. Handled end to end.
PROTACs are bivalent molecules that defy Lipinski’s Rule of Five — typically 700 to 1,000 Da, connecting an E3 ligase ligand and a target warhead via a carefully engineered linker. They are potent, structurally complex, and difficult to purify by conventional crystallization. They require scientists who understand the chemistry, the stereochemistry, and the regulatory expectations from day one.
Ardena has proven experience with PROTAC development and manufacturing.
We know PROTACs. Let’s look at yours.
Our capabilities span
- Small molecule chemistry — standard chemical conversions with a strong focus on stereochemical control
- HPAPI containment — up to OEB-5 (OEL >0.01 µg/m³), handling the conserved phthaloyl-glutarimide ring and other potent structural motifs
- Preparative HPLC purification — where crystallization falls short, our LC200 system delivers
- Solubility enhancement — spray drying (SDD) and hot melt extrusion (HME) for poorly soluble PROTAC molecules with BCS Class II and IV profiles
- Bioanalysis — PK measurements and tissue penetration by LC-MS/MS, PD target protein measurements by ELISA/MSD
- CMC regulatory support — IND/IMPD compilation and Module 3 writing from early phase through late stage
Small molecules. Big mechanism. Serious expertise.
Molecular glues are monovalent targeted protein degraders — typically under 500 Da and within Lipinski’s Rule of Five — but their mechanism of action is anything but simple. Unlike PROTACs, they work through weak binding affinities to both the E3 ligase and the target protein, operating as event-driven catalytic agents that redirect the cell’s own protein degradation machinery. Their targets are often unpredictable. Their development requires scientific judgment, not just protocol.
Ardena applies the same integrated development platform to molecular glues as to all complex modalities.
A small molecule with a complex mechanism needs scientists who understand both.
Integrated development platform
- Physicochemical characterisation — LogP, pKa, PSD, HRXRPD, DSC, TGA-MS, NMR, and more
- Amorphous solid dispersion screening — for solubility challenges that standard formulation cannot solve
- Drug product development — spray drying and HME where bioavailability enhancement is needed
- Bioanalytical support — PK, PD, and biomarker assays phase-appropriate from preclinical through clinical
- CMC regulatory — strategic advice, gap analyses, and dossier writing aligned with FDA and EMA
10+ years of GMP experience. From linker chemistry to clinical supply.
Drug-linker conjugates — ADCs, XDCs, and a growing range of emerging modalities — combine the selectivity of a carrier with the potency of a payload, connected by a linker that must be precisely engineered and controlled. The chemistry is demanding. The containment requirements are strict. The analytical complexity is significant. And the regulatory expectations are high at every stage.
Ardena delivers end-to-end support across the full XDC development arc — make, analyze, file.
10+ years of GMP experience in drug linker and bioconjugation. Your program is in the right place.
End-to-end XDC support
- Drug linker and payload synthesis — route scouting, process and analytical development, scale-up from 1 g to 25 kg. OEL >0.1 µg/m³ now, OEL >0.01 µg/m³ capability by end of 2026
- Conjugation chemistry — SPDP-thiol, Cu-catalyzed and Cu-free click chemistry, thiol-maleimide, EDC-NHS, and more. DAR optimization and conjugation heterogeneity control built into every process
- Purification — preparative HPLC and tangential flow filtration (10 mL to 100 L), with single-use contact materials and broad pore size range
- Cleanroom manufacturing — Grade C and D cleanrooms in our dedicated nanomedicine facility for conjugation and purification of ADCs
- GLP bioanalysis — ~10 years of ADC experience, currently supporting 4 active programs. Total Ab, total ADC, conjugated payload, free payload, and ADA assays across multiple species and matrices
- Drug product — aseptic fill-finish, lyophilization, formulation development, and phase-appropriate analytics
- Clinical supply — packaging, labeling, and global logistics coordination
- CMC regulatory — dossier-centric approach with a proven record of successful IND, IMPD, NDA, and MAA filings
Complex chemistry demands an integrated partner.
Developing these modalities across multiple CDMOs creates gaps — in data, in accountability, and in your timeline. At Ardena, drug substance chemistry, drug product formulation, bioanalysis, and CMC regulatory support are coordinated within one program. The scientists working on your linker chemistry are talking to the scientists designing your bioanalytical assays. That integration is not a marketing claim. It is how we run every program.