15 October 2020 | News
Offering bioanalytical, biomarker and vaccine sciences services for global and China-based biopharma customers
Image credit- shutterstock.com
PPD, Inc., a leading global contract research organization headquartered in the US, is opening a new laboratory in Suzhou, China, to support China-based biotech companies and Western pharmaceutical companies managing China research studies.
The 67,000-square-foot (6,224-square-meter) facility in the Suzhou New District, Jiangsu Province, is expected to be fully operational in 2021, offering bioanalytical, biomarker and vaccine services to support trials across all phases of pharmaceutical development. The company anticipates adding approximately 350 positions as a result of the expansion.
In Suzhou, the bioanalytical lab offering will include services for small molecules, biologics, and cell and gene therapies. The lab will encompass 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 will specialize 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.
The biomarker lab offering will include a range of services applicable across multiple regulatory compliance environments and fit-for-purpose situations. Analysis will be performed with molecular genomics, flow cytometry, ligand binding and LC-MS/MS to support both preclinical and clinical studies. PPD’s alliance with NeoGenomics Laboratories enhances its internal capabilities with extensive immunohistochemistry and molecular test menus. NeoGenomics operates an oncology-focused clinical trials testing lab in the same building as the PPD Laboratories’ central lab in Singapore and plans to establish a similar arrangement in PPD’s new Suzhou facility.
The vaccine sciences lab will provide a full range of testing services specifically designed for vaccine development trials. The lab will employ immunoassays, cell-based assays and multiplexed functional assays for vaccine efficacy and molecular assays for infectious disease monitoring. The lab’s services will span technology assessment and method development to immunogenicity and concomitant studies.
In the Asia-Pacific region, PPD also maintains a central lab in Shanghai that provides support for clinical trials being conducted in China with safety and efficacy testing, custom specimen collection kits and biorepository services. The lab provides high-quality data across a wide range of technologies and applications for all phases of pharmaceutical development. The central lab’s innovative enterprise and information management system, the Preclarus central lab database, delivers data in real time to expedite project teams’ decision-making and help accelerate research.
In addition to the new lab in Suzhou, PPD Laboratories includes bioanalytical labs in Middleton, Wisconsin, and Richmond, Virginia; GMP (good manufacturing practices) labs in Athlone, Ireland, and Middleton; central labs in Shanghai, China, Brussels, Belgium, Highland Heights, Kentucky, and Singapore; biomarker labs in Highland Heights and Richmond; and a vaccine sciences lab in Richmond.