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11/09/2019
CMAB BIOPHARMA RECEIVES POSITIVE OPINION FOLLOWING EXTERNAL QUALITY AUDIT




·        CMAB Biopharma today reports a positive opinion from a recent QP auditconducted by Parexel International Co.

·        CMAB’s fully integrated CDMO facility in Suzhou, China was found toconform to EU Eudralex Vol. 4 Good Manufacturing Practice (GMP) guidelines

·        This achievement signals CMAB Biopharma’s continuing evolution intoan international CDMO capable of supplying European clients.




CMAB Biopharma (Suzhou) Inc. (“CMAB”), a pure-play contract development and manufacturing organization (CDMO) specializing in the production of mammalian cell-derived biologic products, announced today a positive opinion in an external European quality audit conducted by Parexel International Co.


The purpose of the audit was to confirm that CMAB’s quality standards are in line with European GMP, thereby verifying that its quality assurance and control systems can meet the requirements of development, production and testing of biologics for use as clinical investigational medicinal products (IMP) in Europe. The auditors conducted a comprehensive and thorough inspection of the company’s quality systems, production and warehousing facilities, utilities and QC laboratory during the two day inspection, and gave a high appraisal of CMAB.




As noted in the official report, “CMAB was observed to be a company with solid and sound business practices and quality focused goals and objectives. The commitment to quality and their business partners is clear and documented into all their system processes. The structure of their Quality Management System and the management commitment to quality is visible at all processes. The facilities were maintained, organized andfunctional and the company has knowledgeable and well trained staff.”



In addition, the report concluded that, “A comprehensive corporate Quality Management System based on the principles of GMP was in place. CMAB’s premises and equipment were suitable and adequate toensure proper manufacturing, storage, distribution as well as return and destruction activities of medicinal products used in clinical trials. Therefore, the overall impression of CMAB was positive and thus the drug manufacture and associated processes were considered GMP compliant and suitable for Parexel International Co.

Also, CMAB was in compliance with EU EudralexVolume 4 GMP for Medicinal Products for Human and Veterinary Use and fulfillthe requirements for IMP EU import.”



Quote from Dr. Yongzhong Wang, CEO of CMAB Biopharma:

“This result confirms our obligation to international partners and provides externally validated assurance that we conform to all the necessary infrastructure and policies in relation to the quality manufacturing of biologic products. I am immensely proud of the work and diligence that has gone into this review by our excellent quality team within CMAB, and indeed the wider organization, as we pass another milestone in our evolution towards being a fully integrated international CDMO.”



Quotefrom Michael Frizberg, President of CMAB Biopharma International:

“Since founding CMAB Biopharma in July 2017, we have been entirely focused on meeting the stringent requirements of international biologics production and supply, so today’s positive opinion is an incredibly important step in our brief history and we look forward to building more international partnerships.”



About CMAB Biopharma

CMAB is a full-service CDMO dedicated to providing bespoke development and manufacturing services for antibodies and biologics for clients in China and across the globe. Our adaptable, service-oriented business enables clients to take their innovative concepts for tomorrow's medicines from DNA to clinical product today.

To find out more about our fully integrated CDMO services, please send email to: hello@cmabbio.com


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