WuXi’s toxicology facility in Suzhou has received a statement of Good Laboratory Practice (GLP) from the Belgium Scientific Institute of Public Health on behalf of the Organization for Economic Cooperation and Development (OECD) after successfully passing three GLP inspections conducted by the Belgium GLP Monitorate.  GLP is a quality system concerned with the organizational processes and conditions under which health safety studies are planned, performed, monitored, recorded, archived, and reported.

A five-day inspection of the facility was conducted by a team of inspectors from the Belgian national GLP compliance monitoring authority in February 2014.  This facility also successfully passed two previous inspections by the OECD in 2010 and 2012, and also passed two inspections by the SFDA/CFDA.

The Belgian GLP statement for WuXi’s Suzhou toxicology facility further acknowledges the quality of our services, which meets the highest international standards.

 

Related links:

See official press release Here.
WuXi Completes Construction of New Biosafety Testing Facility in Suzhou
WuXi’s Facilities for Late- and Commercial-Stage Analytical and Stability Testing and Clinical-Trial Materials Manufacturing Passes FDA Audit

1 COMMENT

  1. Dear Sirs,

    MetaGenix Therapeutics is developing novel therapies for metabolic diseases, with focus on treatments of fatty liver. Our lead drug, the Ostreolysin (OLY), a small recombinant protein (15KD) produced in E-coli, originally sourced from Pleurotus Ostreatus mushrooms, has been developed by Prof. Betty Schwartz, the Hebrew University over the last five years. MetaGenix own the exclusive worldwide rights for the OLY and its applications.

    OLY is an effective and safe anti – NASH therapy for Intraperitoneal injection. OLY showed promise in preventing fatty liver, and eliminating fatty liver as shown in several obese mice models. OLY reduces liver fat content and improves blood glucose tolerance as well as improving liver functions shown by reduction of transaminase enzymes levels. OLY is hepato-protective enables reduced cellular Bax/Bcl-2 ratio. Please see enclosed summary.

    Can you provide a proposal for the pre-clinical development program (GLP repeated tox studies up to 6 months in rodents and non rodents models – IP injection every other day) as well clinical development program for proof pf concept in NASH obese patients, including phase I/PK study.

    Looking forwards to hearing from you.

    Best regards,

    Avi Gorodn- CEO