Services / Bioanalysis

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.

15+
Years in bioanalysis
800+
Validated methods
FDA EMA
Regulatory submissions
Core Platforms

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)
Our Approach

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
Services

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.

01

Small Molecule Bioanalytical Services

PK and biomarker quantitation of small molecules using validated LC-MS/MS in support of GLP and clinical studies.

02

Large Molecule by Hybrid MS/MS

Hybrid immunoaffinity capture followed by LC-MS/MS quantitation — for peptides, ADCs, and complex biologics.

03

Large Molecule by LBA

PK and biomarker quantitation of biologics via ELISA, MSD, and Gyrolab platforms across all matrices.

04

Biomarker Services

Fit-for-purpose method development and validation for soluble, cellular, and translational biomarkers — supporting target engagement, PD, and patient characterization.

05

Immunogenicity Services

Clinical ADA evaluation according to FDA and EMA guidances and preclinical streamlined ADA evaluation (1-tier approach).

06

Flow Cytometry Services

Built by scientists. From biomarker analysis, RO to advanced immune phenotyping. Scientifically designed flow cytometry panels of up to 12 colors.

07

qPCR Services

RT-qPCR for biodistribution, shedding, gene expression, and vector copy-number readouts.

08

Dose Formulation Services

Concentration, homogeneity, and stability analysis of dosing solutions for nonclinical and clinical studies.

09

Clinical Trial Services

Sample logistics, central lab coordination, and GCLP-compliant bioanalysis across Phase I–IV programs.

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

info@ardena.com