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PPD® Laboratory Services, GMP Lab

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

Our GMP Lab provides high-quality analytical services for small molecules and biologics including active pharmaceutical ingredient, drug product, inhaled and other medical devices for all phases of drug development. As a leading provider of CMC lab services, we focus on responding to our clients’ needs with experienced staff, the latest technology, quality service and a high degree of flexibility.

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.

GMP Lab scientist reviewing a sample.

Our 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

State Of The Art Facilities And Experienced Personnel Supporting

  • Analytical development and validation for drug products and devices, starting materials, APIs, etc.
  • Stability testing and storage
  • Release and quality control testing
  • Inhaled pharmaceutical and biologics testing
  • Physiochemical characterization
  • Specialized expertise in mass spectroscopy
  • Potency bioassay and molecular biology applications
  • Microbiology
  • CMC advisory services
  • Impurity identification and characterization
  • Qualified person (QP) release services
  • Infectivity
Explore our GMP lab capabilities

Our GMP lab met or exceeded expectations for quality of analytical testing for 98% of our customers

WE ARE READY TO PARTNER WITH YOU

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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 700,000 square feet of laboratory space and 2,500+ global employees, our 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

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

Our GMP Lab offers highly customized testing programs designed specifically to your organization and its unique requirements. Our tailored solutions feature extensive testing experience/expertise, and our industry-leading labs enable us to successfully plan, manage and execute your next program no matter where, when or how you need it.

Related Resources

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