GMP Lab Cell and Gene Therapy Expertise

Cell and gene therapies are expected to grow at a rate of 1,000% in the next five years. PPD® Laboratories’ GMP lab has been working with these therapeutics for the past 15 years. Our team leverages more than 25 years of chemistry, manufacturing and control (CMC) experience to offer a comprehensive set of services specifically tailored to the needs of cell and gene therapy development programs.

Expertise in Cell and Gene Therapy

PPD Laboratories has been building its expertise with these complex development programs for nearly two decades and has worked with dozens of cell and gene therapies across a broad range of molecule types. Our expertise includes:

  • Specialized sample handling to minimize nucleases and moisture uptake for hygroscopic substances
  • Developing denaturing HPLC methods
  • Extensive work with complex formulation types
  • Separation methodologies and complete impurity analysis using multiple techniques
  • Transfer of custom-developed analytical techniques for a wide range of cell and gene therapy drug substances
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Years experience with cell and gene therapies

Cell and Gene Therapy Experience and Capabilities

Our wealth of experience with cell and gene therapies includes a variety of drug substances, many different study types and extensive experience with oligonucleotides. At PPD Laboratories, we are dedicated to supporting clients’ cell and gene therapy programs across the phases of drug development.

Drug substances

  • Oligonucleotides, including siRNA, RNAI and DNAI
  • Encapsulated and naked plasmids and mRNAs
  • Viral vectors including adenovirus vectors (AdVs), adeno-associated virus vectors (AAVs), baculoviral vectors (BVs) and lentivirus vectors (LVs)

Study types

  • Analytical method development and validation
  • Drug substance and reference standard characterization across a range of formulations and delivery routes
  • In-process sample analysis
  • Quality control and release testing
  • Stability testing and storage
  • Comparability studies
  • Forced-degradation studies
  • Process and formulation development support
  • Container/closure integrity testing (CCIT)

Extensive oligonucleotide capabilities and cGMP service offering

  • Full compliance with U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations and rules governing medicinal products in the European Union
  • Customized method development, transfer and validation under cGMP
  • Full range of physiochemical and molecular characterization and potency assays
  • Bioburden and endotoxin testing
  • Safety testing

Explore our experience:

PPD Laboratories had experience with more than 60 cell and gene therapies.

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