Absorption Systems' ACF Bioservices Certified by European Agency for GMP-compliant Alternative Therapeutic Medicinal Product Stability and Product Release Testing
Published: Aug 07, 2018
EXTON, Pa., Aug. 7, 2018 /PRNewswire/ -- 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.
About ACF Bioservices
ACF Bioservices (an Absorption Systems Division) has world renowned expertise and experience in analytical support for gene and cell therapy products through every stage of development. Potency assays are on the critical path for product commercialization, and ACF offers de novo development, optimization, qualification, validation, and cGMP-compliant final product stability and release testing services for both allogenic and autologous therapies. Our capabilities include both in vitro and in vivo models, with the goal of predicting human outcomes. Our fully compliant facilities and studies have been inspected by the FDA, EMA, USDA, and AAALAC.
ACF has over 20 years of business operating expertise developing proprietary assays, combining our skills in cell and molecular biology, assay development and validation, bioanalytical and immunochemical quantitation, statistical analysis, and regulatory affairs in a single-source partner. Please contact ACF Bioservices for additional information at acfbioservices.com.
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SOURCE Absorption Systems