WuXi Biologics Received First GMP Certificate of Ireland Site from Ireland Health Products Regulatory Authority
- Only 9 months from the start of operations to the first GMP certificate demonstrating “WuXi Biologics Quality” and “WuXi Biologics Speed”
Dundalk, Ireland, December 28, 2022 – WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has received the first GMP certificate from Ireland Health Products Regulatory Authority (HPRA) for clinical- and commercial-stage product release testing in Dundalk, Ireland. This is the first Manufacturer’s/Importation Authorisation (MIA) and Investigational Medicinal Product (IMP) license, further supporting WuXi Biologics Dundalk to deliver commercial biologics for global clients towards promising treatments for patients.
The three-day inspection covered the QC laboratory, the quality management system and associated warehouse activities of the whole site, resulting in no critical deficiencies nor major deficiencies. The successful outcome from this inspection now allows the QC laboratories to serve as a testing lab for drug substance and drug product.
Dr. Chris Chen, CEO of WuXi Biologics, commented,”We are proud of receiving the first GMP certificate 9 months after the operation of Ireland site. This also represents another remarkable milestone in our efforts to establish premier-quality operations on a global scale. We will continue to strictly adhere to the quality standards set forth by the health authorities, enabling global partners to discover, develop and manufacture biologics for the benefits of patients worldwide.”
More than 400 employees are now working at this Irish site, which has been operational since this March.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 10,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2022, WuXi Biologics is supporting 534 integrated client projects, including 14 in commercial manufacturing.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com.