For more than 30 years, PPD® Laboratories’ bioanalytical lab has been dedicated to helping clients advance their research programs by providing high quality, accurate results across all phases of pharmaceutical development and commercialization.
The bioanalytical lab has significant experience working with small molecules, biologics, vaccines and biomarkers across a wide variety of technologies and therapeutic areas. Our experience spans immunochemistry, chromatography, cell-based assays, flow cytometry and molecular genomics.
Our people are at the heart of our bioanalytical capabilities. Our scientists have extensive experience in bioanalytical testing in labs dedicated to drug and biologics development. Our lab management team members have at least 10 years of experience in contract laboratory environments. Additionally, our executive management team brings expertise and longevity, with each having more than 20 years of industry experience.
We leverage the experience of our leaders, managers and scientists to effectively meet clients’ requirements of accurate, timely, high-quality results with:
- Efficient, timely support of complex analytical challenges
- Advice on procedures/methods to obtain the needed data
- Refined analytical standard operating procedures (SOPs) and lab procedures
Our comprehensive analytical SOPs ensure compliance with good laboratory practice (GLP) and good clinical laboratory practice (GCLP) standards as well as current regulatory guidance documents. Our validated assay list currently includes more than 800 nonproprietary methods and new test methods are being developed on a continual basis in response to our clients’ needs and industry trends.
At PPD Laboratories, vaccine sciences and biomarker development projects are fully integrated with bioanalytical testing. This integrated approach leverages the extensive experience of the bioanalytical lab to enhance the expertise of the vaccine sciences and biomarker teams.
For projects that utilize PPD Laboratories’ central lab, project teams and data can also be integrated. This integration provides additional levels of visibility for key project metrics and real-time access to select data sets in order to inform decisions and reduce the time and cost curve of development.
Unsurpassed Regulatory History
Given the sophistication of today’s pharmaceuticals and the complexity of the development process, a bioanalytical lab partner with broad technical expertise and a strong regulatory history/performance is more important than ever. In a recent Industry Standard Research (ISR) survey, respondents noted technical expertise and regulatory history/performance as the most important criteria for selecting a bioanalytical lab.
PPD® Laboratories met or exceeded client expectations for bioanalytical technical expertise for 97% of PPD clients.1
PPD Laboratories’ bioanalytical lab has successfully completed more than 70 regulatory inspections over the past three decades, including audits of multiple biosimilar programs. This extensive experience has resulted in a deep understanding of regulatory guidelines, requirements and the evolving expectations for bioanalytical clinical data sets. With this knowledge, our team of regulatory and quality experts helps clients navigate and expedite the regulatory process.