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PPD® Laboratories Bioanalytical Lab

Three Decades of Scientific Technical Expertise to Ensure Reliable Data

From generics and biosimilars to cell and gene therapies, every scientific advance brings with it a set of new and sophisticated tools and techniques designed to analyze and evaluate samples with greater speed, precision and certainty.

You need a partner with the scientific acumen to quickly incorporate the latest technology into your bioanalytical studies while simultaneously providing critical guidance on methods that will satisfy regulatory authorities worldwide.

Over the past 30 years, PPD® Laboratories’ bioanalytical lab has helped bring thousands of compounds to market by employing the most technologically advanced systems to develop assays and apply them to clinical trial samples across every stage of drug development.1

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Scientists Across Bioanalytical, Biomarker and Vaccine Specialties

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Validated Methods Including 300+ Non-proprietary Methods

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Success Rate in Meeting or Exceeding Expectations for Bioanalytical Technical Expertise

70+ successful regulatory inspections demonstrate our commitment to quality

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Bioanalytical Lab Video

We have significant experience working with:
  • Small molecules
  • Biologics
  • Vaccines
  • Biomarkers
  • Cell and gene therapies

Explore Our Experience
Our capabilities span a wide variety of technologies and therapeutic areas:
  • Immunochemistry
  • Chromatography
  • Cell-based assays
  • Flow cytometry
  • Molecular genomics
  • Biostatistics
Explore Our Capabilities

Our people are at the heart of our bioanalytical capabilities

Our scientists have extensive experience in bioanalytical testing in labs dedicated to drug and biologics development. With our lab management team having experience ranging from 10 to more than 20 years, we bring expertise and longevity to every project.

We leverage the experience of our leaders, managers and scientists to effectively meet customers’ requirements for accurate, timely, high-quality results.

  • We apply our technical, cross-discipline know-how to provide effective solutions to complex analytical challenges
  • We can provide consultation and guidance on procedures/methods to obtain the best data to meet your specific program goals
  • Our regulatory history demonstrates our ability to comply with GLP and GCLP regulations
  • We have an in-depth understanding of current regulatory guidance documents
  • We can provide full biostatistical support for assay development, qualification and validation, and cut-point analysis for biologics

Our regulatory and quality experts help you navigate and expedite the regulatory process

With rapidly evolving global regulatory guidelines, it is essential that you partner with an experienced and knowledgeable team that can navigate these complexities with ease. PPD Laboratories’ bioanalytical lab has successfully completed more than 70 regulatory inspections over the past three decades, including audits of multiple biosimilar programs such as insulin, adalimumab, etanercept and pegfilgrastim. As a result, we can quickly anticipate and overcome potential regulatory challenges due to evolving expectations for bioanalytical clinical data sets that could pose obstacles to regulatory approvals.

Successful FDA inspection of a cell and gene therapy program in March 2019.

Our integrated approach accelerates informed decisions and reduces time and cost

At PPD Laboratories, vaccine sciences and biomarker development projects are integrated with bioanalytical testing. Our integrated approach leverages our extensive bioanalytical experience to enhance the expertise of the vaccine sciences and biomarker teams.

Read more about our biomarker and vaccine sciences lab capabilities.

Projects utilizing our central lab can also have data and project teams integrated, which provides additional levels of visibility for key project metrics and real-time access to select data sets to enable you to make faster and better decisions about your compound.

Learn More About the Benefits of Partnering with PPD Laboratories.

Download Overview
ppd partner brochure

PPD Laboratories' Bioanalytical Lab Thought Leadership Series

Watch as experts from our bioanalytical, biomarker and vaccine sciences labs in Richmond, Va., take you through trending topics of the bioanalytical landscape ranging from CAR-T cell enumeration to vaccine immunogenicity testing.

Related Resources

Learn more about PPD Laboratories bioanalytical lab