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PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.
PPD, a contract research organization, has opened its new multipurpose laboratory in Suzhou, China, to support Western and China-based pharmaceutical and biotech companies managing China research studies. The 67,000-ft2 facility, located in the Suzhou New District, Jiangsu Province, offers bioanalytical, biomarker, and vaccine laboratory services to support trials across all phases of pharmaceutical development.
The bioanalytical lab in Suzhou includes services for small molecules, biologics, and cell and gene therapies and encompasses multiple technology platforms across a wide range of applications, including ligand-binding immunochemistry, liquid chromatography tandem mass spectrometry (LC–MS/MS), polymerase chain reaction (PCR), and flow cytometry. The lab also specializes in the development and validation of fully compliant robust custom assays for pharmacokinetic/pharmacodynamic (PK/PD) analyses and immunogenicity assessments in both preclinical and clinical studies, PPD said in a May 24, 2021 press release.
The biomarker lab offers a range of services applicable across multiple regulatory compliance environments and fit-for-purpose applications. Analysis can be performed with molecular testing, flow cytometry, ligand binding, and LC–MS/MS to support both preclinical and clinical studies. In addition, an alliance with NeoGenomics Laboratories enhances PPD’s internal capabilities. NeoGenomics operates an oncology-focused clinical trials testing lab in the same building as the PPD Laboratories’ central lab in Singapore. The company has established a similar arrangement with PPD for PPD’s new Suzhou facility.
Meanwhile, the vaccine sciences lab provides a full range of testing services specifically designed for vaccine development trials. This lab employs immunoassays, cell-based assays, and multiplexed functional assays for vaccine efficacy. The lab also uses molecular assays for infectious disease monitoring. The lab’s services range from technology assessment and method development to immunogenicity and concomitant studies.
With this expansion at Suzhou, PPD plans to staff approximately 300 highly skilled professional positions over the next three years. The new lab supplements the company’s existing Shanghai central lab, established in 2015. PPD also plans to add central lab services in Suzhou in 2022 to augment the current capabilities in Shanghai and Singapore.
“With our new state-of-the-art operations, the latest instrumentation and high-throughput automation, we are further equipped to provide high-quality results and data for our customers,” said Christopher Fikry, MD, executive vice-president of PPD Laboratories, in the company press release. “We can now offer an in-country lab facility for clinical studies in China that provides the same capabilities that are available for studies at our other locations around the world. Through scientific excellence and consistent, high-quality delivery of critical data, we will help expedite the drug development process for customers who are either based or doing business in China.”