Cell and Gene Therapy Expertise

PPD® Laboratories' bioanalytical lab has worked with more than 300 cell and gene therapy assays.

Cell and gene therapies are expected to grow at a rate of 1,000% in the next five years. PPD® Laboratories’ bioanalytical lab has been working with these novel therapeutics since 1997. Our team has accumulated a wealth of experience in pharmacokinetic/pharmacodynamic (PK/PD), immunogenicity and molecular genomics, backed by extensive capabilities and strong regulatory experience. At PPD Laboratories, we support clients’ therapies through every stage of the drug development life cycle.

Our dedicated lab development team works closely with clients on their programs and supports a variety of analytes and delivery mechanisms:

  • Oligonucleotides
  • mRNA
  • CAR-T therapy
  • CRISPR/Cas9
  • Enzyme replacement therapy
  • Lipid nanoparticles
  • Polymers
  • Adeno-associated virus (AAV)
  • Targeted delivery mechanisms

Expertise in cell and gene therapy

For the past two decades, PPD Laboratories has been building its expertise with these advanced therapies and has worked with more than 300 cell and gene therapy assays since 1997 to provide:

  • Method development, transfer and validation and sample analysis following U.S. Food and Drug Administration (FDA) good laboratory practices (GLP) customized for cell and gene therapies
  • Analytical expertise across a wide range of common and rare matrices including more than 20 years of experience with tissue processing and analyses
  • Technology selection guidance based upon sensitivity, selectivity, complexity, dynamic range, throughput and specific program needs

Extensive capabilities for cell and gene therapy development programs

PPD Laboratories’ bioanalytical lab provides the exceptional technology and instrumentation and high-quality services required for advanced cell and gene therapy programs in any phase of drug development. Our offerings include:

  • Comprehensive immunochemistry, chromatographic, flow cytometry and molecular services to support preclinical studies and clinical trials Phases I-IV
  • High throughput liquid handling and sample analysis
  • Gene expression product analysis via ELISA, MSD, Gyros, Simoa and additional ligand binding platforms
  • Wide-ranging molecular genomic services including qPCR, digital droplet PCR, Sanger sequencing and next-generation sequencing (NGS) to support preclinical through post-approval
  • Anti-drug antibody and cell or plate-based neutralizing antibody assays for analyte, protein product and delivery vector
  • Bioanalysis by ion-pair liquid chromatography coupled with tandem mass spectrometry (IP-LC-MS/MS) and IP-LC-UV
  • CAR-T cell enumeration for cellular kinetics and immunophenotyping via flow cytometry

Explore our experience:

  • Small Molecule
  • Biologics
  • Biosimilars
  • Generics

  • Vaccines Lab
  • Biomarkers
  • Vaccines Lab


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