ProImmune Receives GLP Accreditation for Cell-Mediated Immune Response Assay Services
News Mar 28, 2011
The accreditation will enable pharmaceutical and biotech companies worldwide to seamlessly incorporate ProImmune’s GLP, as well as GCP (Good Clinical Practice), compliant services, such as cell-mediated immunity assays, into their preclinical and clinical development programs, with the confidence that the data will fully meet the different international regulatory submission requirements.
During the development of biological therapies, assays that reliably measure cellular immune responses are vital in examining the safety and efficacy profiles of the potential therapeutic. Cell-mediated immune response assays are notoriously difficult, time consuming and costly to implement in-house, therefore having access to ProImmune’s GLP and GCP compliant assays provides an outsourcing solution for developers of novel therapies.
Dr Nikolai Schwabe, CEO of ProImmune, said: “We are committed to supporting our global customers’ requirement for understanding and characterizing immune responses during all phases of pharmaceutical product development, including immunogenicity risk assessment and vaccine optimization and development. Obtaining GLP and GCP accreditation demonstrates that our services are consistently performing at a high standard in a regulated environment.”