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Precision Medicine

Molecular bioanalysis

Count on Labcorp's Molecular Bioanalytical Services breadth and depth of scientific expertise to help you along your drug development journey. From cell to gene therapies and biotech to pharma clients, our highly experienced subject matter experts will partner with you to deftly advance your drug development goals along the development continuum.

Precision medicine represents a significant shift in healthcare, moving  from a generalized approach to a more personalized strategy that considers a person's genetic makeup, environmental  and lifestyle. Within this field, cell and gene therapies have emerged as promising tools for improving patient care—with cell therapy involving the transferring of live cells into a patient and gene therapy modifying a person’s genetic code to treat or cure specific health conditions.  

Bioanalysis is crucial for cell and gene therapy development in both the preclinical and clinical phases of drug development. However, given the nature of cell and gene therapies, traditional bioanalytical methodologies and instrumentation originally designed for small and large molecule treatments do not suffice. Specific molecular bioanalytical methodologies and instrumentation for biodistribution, vector shedding, vector copy number, and cellular kinetics are required to advance cell and gene therapies along the drug development continuum.  

Human deoxyribonucleic acid (DNA), computer illustration.

Proven leadership in molecular bioanalytical services

70+

Novel Therapies

20+

years Experience

50+

Methods Annually

4

Global Sites

3d render of T cells attacking cancer cells

With over 20 years of molecular bioanalytical experience and industry thought leadership insights, we can help you advance even your most challenging projects when it matters most. Located across four global sites in the U.S., U.K.and Asia, we are ready to partner with you to help you achieve your next milestone.

Key Areas of Expertise:

Insightful Solutions

  • Method Development
  • Feasibility Assessments
  • Method Transfer
  • Validation
  • Sample Analysis

Molecular Bioanalytical Specialties

  • ATMPs (Advanced Therapy Medicinal Products) - non-regulated, GLP, GCP, and CLIA)
  • Gene and Viral Therapies (AAV, lentiviral, adenoviral, retroviral, oligonucleotides, siRNA)
  • Cell Therapies (e.g., CAR-T, stem cells, iPSC cells)

Study Types

  • Nonclinical Pharmacology,  Toxicology, biodistribution, and shedding
  • Clinical Pharmacology and biodistribution
  • Clinical shedding (including CLIA compliance)

Explore our Molecular Bioanalysis Capabilities

Your innovative therapies deserve cutting-edge support.

Expanded global footprint to serve you better 

Your innovative therapies deserve cutting-edge support. That's why we've recently invested in lab expansions that have quadrupled our capacity in molecular bioanalytical services, meeting the growing complexities of the biopharmaceutical landscape.   

Our recently expanded  footprint  helps reduce lead times for your advanced cell and gene therapies, empowering you with critical speed—without compromising high quality and consistent results. Backed by our 20+ years of molecular bioanalytical experience, our global network is better equipped  to expedite your breakthroughs, whether you're focused on oncology, rare diseases or other therapeutic areas. Our increased scale is your advantage, helping you bring life-saving treatments to patients sooner. 

For more information, read our recent press release.

4 Global Locations:

  • Greenfield, Indiana, USA
  • Harrogate, U.K.
  • Shanghai, China
  • Singapore

Key Molecular Bioanalytical Facts:

80+ Global Staff
10+ PhDs
70+ Cell and Gene Therapy Products Supported
3,000+ PCR Assays Developed

Global excellence, technical precision

Labcorp’s global leadership team maintains consistent quality through aligned technology platforms and standardized operating procedures across all locations. Benefit from our deeply scientific and technical exchange network, providing you with cutting-edge expertise and innovative solutions to drive your therapies forward efficiently and effectively.

For more molecular bioanalysis scientific news and to meet our scientific staff, please visit: https://www.labcorp.com/science/bioanalytical-insights#scientists

Global excellence, technical precision

Recent Labcorp Molecular Bioanalysis Scientific Features

Recent Webinars:

Challenges when designing qPCR/ddPCR assays for cell and gene therapies (June 2024)

Challenges and opportunities for bioanalytical support of new drug modalities (April 2024)

Quantitative approaches for small RNA expression analysis via multi-step RT-qPCR (October 2023)

In the News:

Labcorp Expands Molecular Bioanalytical Laboratory in Greenfield, Indiana

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