MabPlex has leveraged a variety of international mainstream brand equipment for independent production lines to carry out multiple CMO manufacturing processes designed to meet the varying needs of its global customers.
SAN DIEGO and YANTAI, China (PRWEB) February 25, 2020
MabPlex International, Ltd., (MabPlex), a leading, fully integrated, Contract Development and Manufacturing Organization (CDMO) serving the global biopharmaceutical and biotechnology industries with sites in China and the United States, has started operations of two cell culture production lines of GE brand 2,000-liter single-use bioreactors. With the added expansion, MabPlex demonstrates the company's commitment to expand further and diversify its capacity after successfully running cell culture lines using Sartorius brand 2,000-liter disposable bioreactors.
It took less than three months from installation to verification to trial operation for the new production lines to come online, reflecting MabPlex's speed of service.
With the expansion of these two new GE brand production lines, MabPlex demonstrates the rich experience of running different types of reactors, which can flexibly meet the diverse CDMO service demands of customers. This one-stop CDMO approach provides a higher degree of flexibility and responsiveness in the ever-increasing need for more complex biomolecules.
By the end of March 2020, MabPlex will launch an additional two production lines featuring Thermo-Fisher 2,000-liter disposable bioreactors, which will provide sufficient capacity for customers' clinical production.
As a professional biomedical CDMO, MabPlex's business approach focuses on "Customer Demands." To provide customers with efficient one-stop CDMO services, MabPlex's facility design, including production line layout and equipment configuration, is based on specific customer needs and requirements.
"MabPlex offers one of the few globally integrated service platforms with high production capacity, something that is unique in our industry," said Yongjian Wu, Ph.D. as Chief Operating Officer (COO) of MabPlex USA.
The company employs a world-class professional team with diverse project management and operational experience, including robust technical and quality systems, large-capacity current cGMP facilities designed in full compliance with Chinese, European, and United States' quality systems. MabPlex has introduced a variety of international mainstream brand equipment for independent production lines to carry out multiple CMO manufacturing processes designed to meet the varying needs of its global customers.
MabPlex approach, offering a "Factory Built for Customers," significantly reduces customer cost and shortens their drug-to-market cycle, contributing to the early access of quality drugs to meet the unmet medical needs of patients.
MabPlex International, Ltd., (MabPlex), a leading and fully integrated, global Contract Development and Manufacturing Organization (CDMO), offers an advanced biologics platform and comprehensive and integrated solutions to global (bio-) pharmaceutical developers. Founded in 2013, MabPlex currently has two sites in China (Yantai and Shanghai) and one site in the United States (San Diego, CA) offering high-quality services from biologics drug development to commercial manufacturing. MabPlex currently has over 60,000 square meters of R&D and production facilities, a total of 9 monoclonal antibodies (mAb) Drug Substance (DS) production lines, 2 Antibody-drug Conjugate (ADC) DS production lines, as well as mAb formulation and ADC formulation lines. The commercial production service designed to help customers accelerate the progress of clinical trials and support a market launch.
MabPlex has established a talented team of more than 400 employees providing Contract Development and Manufacturing Organization (CDMO) services to more than 40 pharmaceutical companies around the world resulting in more than 12 Investigational New Drug application (IND) approvals with the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and China's National Medical Products Administration (NMPA). For more information, please visit our website at https://mabplexinc.com/