PPD Laboratory Services, Vaccine Sciences Lab
We drive vaccine development with well-defined assays
Our vaccine sciences lab builds upon three decades of pharmaceutical development expertise to support your vaccine programs at any development stage from pre-clinical through post-approval.
Our extensive capabilities ensure development of innovative analytical methods and accurate, high-quality and rapid vaccine test results. The PPD™ clinical research business of Thermo Fisher Scientific helps you achieve the highest scientific standards for your program while focusing on efficiencies.
We offer a full range of services across a wide variety of vaccines from legacy childhood diseases and seasonal flu to endemic pathogens and novel therapeutic vaccines.
Our services include:
- Antigen detection/quantitative RT-PCR/sequencing
- Traditional and multiplex immunoassays
- Virus Neutralization assays (VNA/MNT)
- Cell-mediated immunity methods
- Viral and bacterial functional assays
- Statistical support services:
- 21 years’ experience
- Routinely provide reports for assay qualification, validations, transfers, optimization, reagent qualification, stability studies, relative-potency rate
- Recommend assay acceptance criteria
- Design of experiments (DOE)
- Support for regulatory responses
- Reference standard calibration
Named “Best Central/Specialty Laboratory” at the 16th Annual Vaccine Industry Excellence Awards
Extensive regulatory experience including 21 FDA or EMA-approved vaccines
Scientists
Square-foot Vaccine Labs
Years of Experience
Our culture of excellence starts with our leadership
Our senior team of scientists has been directly involved in the development of the assays used to license a large number of marketed vaccines. They are recognized thought leaders in their individual disciplines and they are active in industry conferences and discussions. These key individuals are also involved in establishing best practices for national and international regulatory agencies. As a customer, you will have access to this dedicated team of experts to help guide and expedite each vaccine development project.
We also have an experienced biostatistics group that is fully integrated into our lab operations. They support the development, qualification, validation and routine maintenance of vaccine assays with a proprietary, fully electronic platform developed to support biofunctional assays and other serial dilution assays and molecular genomics.
Our regulatory experts can help expedite the approval process through in-depth knowledge of FDA requirements and evolving expectations experienced over the course of 489 local FDA audits. We have supported the licensure of more than a dozen new vaccines with assay development, high-throughput testing and responses to regulatory agencies post-submission.
We provide integrated clinical and laboratory vaccine expertise and global resources to advance your vaccine programs
We work with customers of all sizes across a wide spectrum of vaccine programs, from legacy vaccines to emerging pathogens.
Our robust end-to-end development solutions include:
- Dedicated vaccine sciences lab for specialized vaccine assays
- GMP, bioanalytical and central labs for vaccine product and safety testing
- Clinical development with more than 145 vaccine studies supported in the past five years
- Partnerships with global sites and networks to support rapid startup and timely enrollment
- An integrated technology platform that links data across sites and laboratories
