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PPD® Laboratories GMP Lab

GMP LAB SERVICES BACKED BY THREE DECADES OF CMC PHARMACEUTICAL TESTING EXPERIENCE

Our GMP lab successfully navigates the rapidly evolving chemistry, manufacturing and controls (CMC) landscape with deep scientific expertise and integrated analytical services across all phases of drug development and commercialization.

We carry out CMC testing following current good manufacturing practices (cGMP) for all types of pharmaceutical products across all phases of development. Our highly qualified GMP lab scientists work with small molecules and biologics, including active pharmaceutical ingredients (API), drug products, inhaled products, cell and gene therapies, and drug-device combination products.

PPD® LABORATORIES GMP LAB CAN HELP SHORTEN YOUR DEVELOPMENT TIMELINES

Wide-Ranging Expertise Industry-leading expertise in the analysis of small molecules, biologics, and cell and gene therapies
Innovative Staffing Model Customized functional service partnership (FSP) solutions to increase efficiencies
Extensive Experience More than 30 years’ experience with all dosage forms
Customizable Solutions Flexible approach to meet customer and market needs

GMP LAB EXPERTISE AND WELL-DESIGNED SOLUTIONS FOR EVEN YOUR MOST COMPLEX PROGRAMS

  • Analytical development
  • Validation of methods
  • Stability management, testing and storage services
  • Release and quality control (QC) testing
  • Physicochemical characterization
  • Extractables and leachables (E&L) analyses
  • Inhaled pharmaceuticals testing
  • Small molecule, biologics, and cell and gene therapy products
  • Functionality testing (injectables)
Explore our GMP lab capabilities

PPD Laboratories GMP lab met or exceeded expectations for quality of analytical testing for 98% of our customers.

WE ARE READY TO PARTNER WITH YOU

Contact PPD Laboratories’ GMP lab to get started.

GMP LAB HISTORY OF GROWTH

Founded three decades ago with only a handful of scientists and less than 25,000 square feet of laboratory space, our GMP lab has grown to more than 15 times its original size and has significantly expanded our service offerings. With locations in the U.S. and Europe, more than 490,000 square feet of laboratory space and 2,000 global employees, PPD Laboratories’ GMP lab has a deep-rooted commitment and strong global presence to keep pace with growing and changing industry needs.

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square feet of lab space in the U.S and Europe

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scientists and staff across the globe

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years of meeting customers’ CMC testing needs

PUTTING OUR GMP LAB EXPERIENCE INTO PRACTICE

Our specialized, cross-functional teams draw upon their deep industry and CMC pharmaceutical testing experience to create an innovative plan for your program that satisfies or exceeds regulatory, timeline and budget requirements. We collaborate with your team from the start to fully understand your goals, explore the most appropriate technology and methodology, and provide critical insights on experimental design.

NITROSAMINES ANALYSIS CASE STUDY

Customized assay development case study

PPD Laboratories Functional Service Partnerships (FSP): Our team is one with your team

PPD Laboratories was one of the first CRO labs to address the persistent challenges associated with temporary staff that move from one project to the next. We apply dedicated, permanent, PPD Laboratories employees to every program to ensure consistency, quality and dedication throughout the course of your study.

Related Resources

Learn more about PPD Laboratories’ GMP lab.