EXTON, PA — Absorption Systems® and its ACF Bioservices™ subsidiary announced that they have been certified by the European Medicines and Healthcare products Regulatory Agency (MHRA). This certification paves the way for ACF Bioservices to provide analytical testing services in support of commercially manufactured and distributed gene therapy products, both for human and veterinary use, within the European Union (EU).
The certificate, number UK GMP 49634 Insp GMP 49634/18377255-0001, can be viewed on the Eudra website: http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do. This European certification warrants that the facility is in compliance with the requirements of Good Manufacturing Practices (GMPs), and is the result of an inspection by the MHRA in April 2018.
According to Karen Donhauser, Director of the GMP Core Facility, “The European certification validates all the hard work that has gone into building, equipping, staffing, and operating our dedicated GMP facility. It’s gratifying to know that we are now able to support innovative gene therapy and cell therapy products that are manufactured and/or distributed in Europe.”
ACF Bioservices has emerged as a leader in developing quantitative cell-based in vitro potency assays to support product release requirements for pharmaceutical, biological, cell therapy, and gene therapy products. This work is performed in its GMP-compliant 3400-square-foot facility that is dedicated to GMP gene therapy and cell therapy analytical product testing.
ACF Bioservices’ parent company, Absorption Systems, is a world leader in developing GLP-compliant in vitro cell-based models utilizing a wide range of molecular biology and cell biology techniques to develop proprietary models for clients in the small molecule and gene/cell therapy space.
Source: Absorption Systems, 436 Creamery Way Ste 600g, Exton PA 19341
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