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MabPlex International has been recognized by Life Sciences Review Magazine as the exclusive recipient of “Top 10 CROs - 2021,” based on our proprietary methodology, reflecting its position in the industry. This profile has been developed by the Life Sciences Review research and editorial team based on insights from an interview with , .

MabPlex International
Multifaceted CDMO for ADC Drug Development

MabPlex International

Jianmin Fang, Founding Chairman,  Wei Chen, CEO, Xinfang Li, President, Scott Cooper, San Diego Site Head, Jennifer Kuo, Sr. Dir BD, MabPlex InternationalJianmin Fang, Founding Chairman, Wei Chen, CEO, Xinfang Li, President, Scott Cooper, San Diego Site Head, Jennifer Kuo, Sr. Dir BD
With tremendous potential, particularly in cancer treatment, the market for antibody-drug conjugates (ADCs) is witnessing rapid growth. However, the manufacturing of ADC drugs presents a unique set of challenges. Moving an ADC drug development program through a complex supply chain, in which several manufacturing facilities are tasked with producing the antibody, payload, linker, conjugate, and final drug product can add substantial time, cost, and difficulty to the process. In addition to this, the accuracy and reliability needed to handle ADC’s potent and costly materials also present a big challenge. To cover such an extensive and diversified range of activities entailing discovery, development, and commercialization, pharmaceutical companies need an all-rounder CDMO experienced in minimizing risk and assuring product quality. Delivering just that is MabPlex International.

MabPlex is a specialized global CDMO that offers effective and high-quality solutions for bringing monoclonal antibody therapeutics and ADC to the biopharmaceutical market. As a one-stop-shop for its partners, MabPlex provides services, all the way from early-stage development to commercialization, covering the entire spectrum—from gene sequencing, cell line development, process characterization, conjugation optimization to Current Good Manufacturing Practice (cGMP) for clinical and commercial manufacturing of final drug product. “Relying on extensive experience and advanced equipment, we provide high-quality service in accordance with the specific needs of our clients,” mentions Wei Chen, CEO of MabPlex.

“Relying on extensive experience and advanced equipment, we provide high-quality service in accordance with the specific needs of our clients

While the company provides upstream process service with various cell culture systems and advanced in-process analytical technologies, it offers downstream process services for various biologics, including monoclonal antibodies and recombinant proteins. The company also maintains high-quality control and helps its clients in scaling up. In effect, as one of the leading companies for ADC drug development, MabPlex sets the standard for ADC drug development. Combining its technical expertise and years of experience, the company can accelerate the ADC drug development across the clinical phase that involves developing a prototype, the research and testing front, and in regards to filing for regulatory ID and getting market approvals. MabPlex also assists its partners in navigating complex regulatory processes and advance programs into the clinic and commercial. The company is well into being recognized by NMPA China, US FDA, EMA, and Australian regulatory agencies.

Chen adds, “Through our constant efforts to meet the growing demands of our clients, we have successfully reduced the product rollout by 4-5 months, on average. This has allowed our clients to save huge costs.” He shares an instance about one such client who had a unique antibody model and planned on developing about a dozen products. To this end, MabPlex helped the client pass a few product molecules from an POC standpoint. The company is even in a position to assist the clients’ partners in product development.

Having a well-established presence in China has enabled MabPlex International to help its global clients by utilizing raw materials manufactured in China, which has enabled them to save money and time and increase their products' value. MabPlex also has an early-stage development team of scientists in San Diego that can work on daily interaction with the client in the US.

Having carved a unique niche in the space, looking ahead, MabPlex will focus on enhancing the early-stage development of products. Marking an upward growth trajectory, the company is planning to launch its IPO next year. As part of its expansion plan for the next two years, the company will extend into the east coast of the US and will be looking at potential growth in Europe. Further expanding its territory in China, the company will soon acquire new land for commercial manufacturing and establish a center of excellence in the United States. The future looks bright for MabPlex.

Top 10 CROs - 2021
Current Issue

Company : MabPlex International

Management
Jianmin Fang, Founding Chairman, Wei Chen, CEO, Xinfang Li, President, Scott Cooper, San Diego Site Head, Jennifer Kuo, Sr. Dir BD

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