LATEST PUBMED ARTICLE

Clinical and technical validation studies for diagnostic companies

• Detection of nonhemagglutinating influenza a(h3) viruses by enzyme-linked immunosorbent assay in quantitative influenza virus culture.
• Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA.
• Comparison of the Abbott Realtime HIV-1 and HCV viral load assays with commercial competitor assays.
• Evaluation of the analytical performance of the new Abbott RealTime RT-PCRs for the quantitative detection of HCV and HIV-1 RNA.
• Multicenter evaluation of the new Abbott RealTime assays for quantitative detection of human immunodeficiency virus type 1 and hepatitis C virus RNA.

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LATEST PRESS RELEASE

Viroclinics Biosciences endorsed for GLP compliancy

Viroclinics Biosciences serves as a virology contract research organization in the bio pharmaceutical community with preclinical, clinical diagnostic, assay development and clinical trial logistics services. Especially with extensive experience in clinical and preclinical studies for viruses, Viroclinics Biosciences supports the development of vaccines, antibodies and antiviral compounds targeting viral infectious diseases. In June 2017 the Health Care Inspectorate, Ministry of Health, Welfare and Sport of the Netherlands endorsed Viroclinics for integrating the Good Laboratory Practice (GLP) methodology for safety testing on vaccines and antiviral agents. This endorsement is a confirmation of the high quality standard of the existing quality management system, which consists of:

– NEN-EN-ISO 15189, Medical Laboratories – Requirements for quality and competence;
– Good Clinical Practice Methodology;
– Good Clinical Laboratory Practice;
– And from now on: Good Laboratory Practices.

Internally, the quality standards are monitored by an independent quality assurance department. On a regular basis, the Dutch Accreditation Council (Raad van Accreditatie), audits and visits the facilities for the confirmation of accreditation of the NEN-EN-ISO 15189, Medical Laboratories – Requirements for quality and competence. Customers and contract organizations belonging to the top 10 Bio-pharmaceutical companies are auditing Viroclinics on a regular basis. GLP is designed to secure non-clinical safety, reliability and consistency of the drug development process. According to the WHO (World Health Organization), there are five fundamental points of GLP: resources, characterization, rules, results and quality assurance. These focal topics were already covered by the current quality management system.

“Good laboratory practices and high quality standards have always been part of our company-DNA. In fact, we see them as important fundamental pillars of our long-term growth strategy. With a full GLP implementation, we are confident that we will exceed our customers’ ambitious quality targets”.

Bob van Gemen, CEO Viroclinics Biosciences

“The OECD’s GLP endorsement is an important milestone. Although an impressive achievement, we do understand that good laboratory practice never stops. It is a continuous improvement process. Therefore we have implemented a quality driven culture in our organization, based on open dialogue and continuous learning & development”

Elina van Herwijnen, VP Quality Assurance


Additional information

Here, you will learn more about Viroclinics Biosciences’ contributions to quality management.

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