Bioanalysis Services

With a wealth of expertise, Pharmaron’s scientists excel in tackling complex bioanalytical challenges. Our specialized teams detect and quantify small molecules, biologics, and cell & gene therapy products across various biological matrices. We deliver effective solutions to quantify compounds, metabolites, and biomarkers, covering all bioanalysis testing needs.

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Excellence through compliance:

Pharmaron’s bioanalysis service unit, with labs in China, the US, the UK, and Japan, is committed to maintaining high international standards. Certified for GLP, GCLP, and GMP, we provide alignment across discovery, preclinical, clinical, and post-marketing phases for seamless drug development processes globally.

Confidence through regulatory expertise:

Pharmaron is a trusted CRO in the bioanalysis space. Our facilities undergo regular, successful FDA, MHRA, OECD, NMPA, and EMA inspections. Our regulatory affairs teams, which collaborate directly with the authorities, support clients.

Consistency through one CRO:

We ensure seamless transitions across every stage of bioanalysis – from assay development and validation/qualification to screening, data interpretation, and problem-solving. Working with one CRO and a dedicated project manager simplifies oversight and reduces logistical complexities.

Flexibility through the entire drug discovery and development process:

Pharmaron’s global workforce is adept at tailoring resources to meet the unique demands of any client project, whether it involves small-scale discovery studies or extensive global clinical trials. Minimizing assay transfers, we help clients save time and cost while significantly reducing the risk of data inconsistencies.

Pharmaron’s Bioanalysis Service Offering

Small Molecule Bioanalysis

?Small Molecule Bioanalysis

Pharmaron’s small molecule bioanalysis services support every stage of drug development, from discovery through preclinical and clinical studies.

Leveraging advanced LC-MS/MS technology, we deliver accurate and precise quantitation of small molecules, ensuring high-quality data for decision-making.

From method development and validation to sample analysis, our expertise and commitment to regulatory compliance provide reliable results tailored to meet your program’s unique requirements.

Discovery Bioanalysis of Small Molecules

Preclinical Bioanalysis of Small Molecules

Clinical Bioanalysis of Small Molecules

Large Molecule Bioanalysis

Pharmaron’s large molecule bioanalysis services address the complexities of biologics development across discovery, preclinical, and clinical phases.

Utilizing advanced platforms, we combine immunoassay
and mass spectrometry techniques to deliver sensitive, specific, and accurate
results for a wide range of large molecules, including proteins, fusion
proteins, antibodies, bispecific antibodies, ADCs, PDCs, and nanobodies, among
others.

Our bioanalysis teams specialize in humoral and cellular immunogenicity testing (ADA, NAb, etc.), leveraging extensive experience in characterization of immune responses to complex therapeutics.

Whether you require method development, validation, or sample analysis, we provide high-quality, compliant data to support the successful advancement of your biologics programs.

Discovery Bioanalysis of Large Molecules

Preclinical Bioanalysis of Large Molecules

Clinical Bioanalysis of Large Molecules

Cell and Gene Therapy Bioanalysis

Bioanalysis testing is crucial to support pharmacokinetic, safety and efficacy studies for the discovery and development of new cell and gene therapies (CGT).

Our bioanalysis support for CGT studies includes:

Biodistribution/viral shedding analysis
NAb and ADA testing
Cellular immunogenicity
Biomarker and cytokine analysis
GLP sample analysis for preclinical assessment and clinical trials

Visit our Cell and Gene Therapy Bioanalysis Page

Carbon-14 Bioanalysis

Pharmaron’s ¹⁴C bioanalysis integrated services offer comprehensive solutions for both traditional and advanced radiolabel studies. Utilizing advanced accelerator mass spectrometry (AMS – SSAMS and LEA systems) technology, we provide ultra-sensitive quantitation of ¹⁴C-labeled compounds, enabling precise measurement at extremely low concentrations. This approach is ideal for ADME (absorption, distribution, metabolism, and excretion) assessments, mass balance studies and metabolite profiling, and absolute bioavailability studies, as well as other specialized applications in drug development.

In addition to AMS, we offer traditional ¹⁴C bioanalytical services, including quantitative whole-body autoradiography (QWBA) and microautoradiography (MARG) imaging techniques, to deliver detailed insights into tissue distribution and pharmacokinetics.

Our expertise in both traditional and AMS-based ¹⁴C methodologies enables us to support a wide range of discovery, preclinical, and clinical programs with exceptional sensitivity, accuracy, and regulatory compliance.

Visit our Carbon-14 Bioanalysis Page

Biomarker Bioanalysis

Pharmaron delivers accurate and reliable biomarker analysis using a variety of singleplex and multiplex methods across discovery, preclinical, and clinical phases.

Our tailored solutions accommodate both low- and high-volume sample testing needs for all relevant matrices like serum, plasma, and tissue homogenates.

With CLIA-certified testing and validations aligned to regulatory expectations, we ensure precise results and analytical suitability, offering expertise in custom biomarker assay development.

Visit our Biomarker Bioanalysis Page

Successful Bioanalysis Starts with a Team of Experts Covering Every Area of Expertise

Pharmaron brings together an exceptional team of global bioanalytical leaders, combining vast collective experience with an innovative perspective rooted in scientific excellence. As bioanalysis has evolved into diverse branches, our experts excel across every area, spanning all modalities and analytical platforms.

Years of excellence in bioanalysis services

Bioanalysis studies conducted

Clinical trials supported to date

LC-MS/MS is performed by scientist loading an HPLC machine to prepare sample for mass spectrometry.

Broad Coverage of Drug Types and Analytes

Choosing a CRO that can detect and quantify all major types of analytes, including the compound itself, its metabolites, biomarkers, and radiolabeled compounds, helps streamline a drug discovery and development program.

Small molecules
Antibodies, incl. nanobodies and multi-specific antibodies
ADCs, PDCs, ACOs, and RDCs
Nucleic acid-based therapeutics, incl. oligonucleotides and nucleotides
Peptides and proteins
Lipids, steroids, and LNPs
Carbohydrates and polysaccharides
Cell and gene therapy products
Vaccines
and more

bioanalysis is performed on a UHPLC for metabolite profiling

Accuracy through Sensitivity, Selectivity, and Ruggedness

We invest in the most sensitive bioanalysis technologies to detect low-concentration analytes and biomarkers to support drug discovery and development. Our experts have expertise in challenging projects such as microdosing studies, detecting trace levels in environmental monitoring, or detecting biologics or cell populations that require accurate quantification at low levels.

A selection of our most sensitive bioanalysis instrumentation:

Ultra-Performance Liquid Chromatography with Tandem Mass Spectrometry (UPLC-MS/MS)
ELISA, MSD, Ella, and Gyrolab automated immunoassay systems
High-Resolution Mass Spectrometry (HRMS)
Accelerator Mass Spectrometry (SSAMS and LEA)
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Capillary Electrophoresis (CE)
Flow cytometry
Digital Droplet PCR (ddPCR)

The BenchCel 4R microplate handler enables high-throughput bioanalysis testing

Pharmaron’s Timely Bioanalysis Services

Our clients benefit from our fast turnaround times and commitment to timely results.

Here are some examples of what you can expect:

2 to 3 days for bioanalysis of small molecules for non-GLP PK study
2 to 3 weeks for GLP method development for small molecules and peptides
Up to 5 days for GLP sample analysis with an option for expedited analysis within 3 days