We know bioanalysis
Our bioanalytical team combines deep scientific expertise with real accountability. We design the right studies, validate the right methods, and deliver the right data. From first sample to final submission.
Subject Matter Experts
Bioanalysis Facilities
The right platform for the right question
We don't apply the same platform to every problem. Our scientists select and validate the right technology for your molecule, your matrix, and your regulatory context.
Liquid Chromatography Mass Spectrometry
01 / PLATFORM
Gold-standard quantitation for small molecules, peptides, and protein biomarkers. Triple-quadrupole and high-resolution accurate mass instrumentation, operated by scientists who know where the sensitivity challenges hide.
- LC-MS/MS
- HRMS
- Hybrid LBA-MS
Ligand Binding Assay Platforms
02 / PLATFORM
High-sensitivity protein quantitation across PK and biomarker programs. ELISA, MSD, and Gyrolab – selected for your molecule, validated for your submission.
- MSD
- Gyrolab
- ELISA
- AlphaLISA
- Ella
Cell-Based Assay Platforms
03 / PLATFORM
Functional and mechanistic readouts that connect your in-vitro pharmacology to downstream bioanalysis. Designed for the biologics and advanced modalities that need more than a standard assay.
- Flowcytometry
- qPCR
- Cell culture-based assays (BSL-2)
We know your molecule
Every bioanalytical program at Ardena is run by scientists who understand the full development context – not technicians following a protocol. We anticipate problems before they appear and solve them before they cost you time.
— Pillar #01
Scientific support on every platform
Dedicated scientists embedded across every method we run – from study design through validation, sample analysis, troubleshooting, and regulatory submission. Your project is never handed to a queue.
- Embedded study scientists from day one
- Fit-for-purpose method development & validation
- Regulatory consultation and submission support
— Pillar #02
High-level expertise across modalities
Decades of combined experience across small molecules, biologics, ADCs, peptides, oligonucleotides, and cell and gene therapies. We bring scientific judgment, not just scientific process.
- PhD-led scientific teams across disciplines
- Fluency in small & large molecule modalities
- Advanced modalities: ADCs, oligos, gene & cell therapy, TPD's (targeted Protein Degraders)
— Pillar #03
Simple solutions to complex science
Complex science needs clear thinking. Our senior scientists engage directly with your program — no gatekeepers, no hand-offs. Just straight answers and a clear path forward.
- Engaged, collaborative project teams
- Complexity distilled into clear paths forward
- Direct access to senior scientists, not gatekeepers
We know bioanalysis. From first sample to final submission.
Nine service areas. One integrated team. Everything your program needs to move from discovery to regulatory submission without the gaps.
Small Molecule Bioanalytical Services
PK and biomarker quantitation of small molecules using validated LC-MS/MS in support of GLP and clinical studies.
Large Molecule by Hybrid MS/MS
Hybrid immunoaffinity capture followed by LC-MS/MS quantitation — for peptides, ADCs, and complex biologics.
Large Molecule by LBA
PK and biomarker quantitation of biologics via ELISA, MSD, and Gyrolab platforms across all matrices.
Biomarker Services
Fit-for-purpose method development and validation for soluble, cellular, and translational biomarkers — supporting target engagement, PD, and patient characterization.
Immunogenicity Services
Clinical ADA evaluation according to FDA and EMA guidances and preclinical streamlined ADA evaluation (1-tier approach).
Flow Cytometry Services
Built by scientists. From biomarker analysis, RO to advanced immune phenotyping. Scientifically designed flow cytometry panels of up to 12 colors.
qPCR Services
RT-qPCR for biodistribution, shedding, gene expression, and vector copy-number readouts.
Dose Formulation Services
Concentration, homogeneity, and stability analysis of dosing solutions for nonclinical and clinical studies.
Clinical Trial Services
Sample logistics, central lab coordination, and GCLP-compliant bioanalysis across Phase I–IV programs.
Related Resources
Our expert team members share deep, scientific understanding and insights into bioanalysis.
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Info sheets
Secondary Packaging Built for Complex Clinical Trials
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Info sheets
Flow Cytometry with Ardena: Bespoke, Backbone and Built
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Case studies
Enabling Complex Phase IIa Dosing Through Flexible Clinical Packaging Design
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Whitepapers
Advancing Pharmaceutical Production: The Benefits of Flow Manufacturing for Nanomedicines
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Info sheets
ADC & XDC Development, from Chemistry to Clinic
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Application Note
Informatics-Supported Solid Form Selection
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Case studies
Achieving High Drug Tolerance in ADA Testing for a Long-Acting Monoclonal Antibody
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Webinars
On-Demand Webinar: Nanomedicine Development from Lab to Clinic: Strategies to Overcome Scale-Up and Analytical Challenges
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Whitepapers
Evolution of Stability Guidelines: From the ICH Q1A-F Series to the Consolidated ICH Q1 Guideline
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