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PPD® Laboratory Services, Bioanalytical Lab

A TRUSTED BIOANALYTICAL LAB FOR MORE THAN THREE DECADES

From non-proprietary assays 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 great speed, precision and certainty. You need a partner with the scientific acumen to quickly incorporate the latest technology into your bioanalysis studies while simultaneously providing critical guidance on methods that will satisfy regulatory authorities.

Over the past 30 years, our 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.

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Scientists across bioanalytical, biomarker and vaccine specialties

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Validated methods

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Square feet of lab space globally

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We have significant bioanalytical experience working with:
  • Small molecules
  • Biologics
  • Vaccines
  • Biomarkers
  • Cell and gene therapies
  • Biosimilars
Explore our extensive bioanalytical lab experience
ViLA
Our capabilities span a wide variety of technologies and therapeutic areas:
  • Immunochemistry
  • Chromatography
  • Cell-based assays
  • Flow cytometry
  • Molecular genomics
  • Biostatistics
Explore our wide-ranging bioanalytical lab capabilities

EXPLORE OUR FLAGSHIP LABORATORY IN RICHMOND, VIRGINIA

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.

Our bioanalytical lab leverages 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.
  • We have 25+ years of vaccine experience and specialize in molecular, neutralization, and viral and bacterial functional assays.
Explore our Bioanalytical Lab capabilities

OUR INTEGRATED APPROACH ACCELERATES INFORMED DECISIONS AND REDUCES TIME AND COST

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 OUR PRECLARUS LAB SOLUTIONS

When working with our bioanalytical lab, customers leverage integration of both our vaccine sciences lab and our biomarker lab for their projects. This integrated approach leverages our extensive bioanalytical experience to enhance the expertise of the vaccine sciences and biomarker teams.

OUR EXPERTS HELP YOU NAVIGATE AND EXPEDITE THE COMPLEX 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. Our bioanalytical lab has successfully completed more than 80 regulatory inspections over the past three decades, including audits of multiple programs across lab disciplines. 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.

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Successful Regulatory Inspections Over the Past Three Decades

LEARN MORE ABOUT OUR VACCINE SCIENCES AND BIOMARKER LABS

TECH TALKS: PPD LABORATORY SERVICES, BIOANALYTICAL LAB

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

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Learn more about our bioanalytical lab