Le Lézard
Classified in: Health
Subject: ACC

CMAB Biopharma Receives Positive Opinion Following External Quality Audit


SUZHOU, China, Sept. 5, 2019 /PRNewswire/ -- 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 and functional 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 to ensure 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 Eudralex Volume 4 GMP for Medicinal Products for Human and Veterinary Use and fulfill the 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."

Quote from 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 visit www.cmabbio.com/en.

For more information contact:

Nicole Zhang
+86-157-2012-5393
Nicole.Zhang@cmabbio.com

SOURCE CMAB Biopharma Limited


These press releases may also interest you

at 15:45
Stealth Power and Braun Ambulances will debut a custom-built Duke University Life Flight ambulance at EMS World Expo 2019 in New Orleans on October 16, 2019. This ambulance is equipped with Stealth Power's Automatic Idle Reduction System (SPAIRS),...

at 15:43
American Skin Association (ASA) announced its grant renewal for a second year of support for SPOTS (Sun Protection Outreach Teaching by Students), a public health outreach educational program taught by medical school students and aimed at middle and...

at 15:35
Cognosante, a leader in information technology solutions and services for Federal and state public health agencies, announced today that Jamil Hermes has joined as Chief Growth Officer. In this role, Hermes will focus on developing and launching...

at 15:29
Anesthesia Business Consultants (ABC), a leading provider in billing and practice management for the anesthesia and pain management specialty, is pleased to announce they will be attending the ANESTHESIOLOGY® 2019 Annual Meeting in Orlando, FL, held...

at 15:20
The American Academy of Stem Cell Physicians has provided an industry standard for Physicians who use regenerative therapies in their practice. The AASCP has recently discussed safety industry guidelines with The American Academy of Environmental...

at 15:10
MemoryCare.com, a comprehensive resource for caregivers and older adults living with memory impairment, has announced the Best Memory Care Facilities in Atlanta, Georgia. The guide identifies 20 memory care communities based on location, access to...



News published on 5 september 2019 at 06:32 and distributed by: