MabPlex
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Fremont, California, US
MabPlex provides global CDMO services in development and manufacturing of biopharmaceuticals, including mAbs, recombinant proteins, ADCs, bispecifics and biosimilars, from upstream cell line development and process development to manufacturing of commercial products. We offer our partners contract services from DNA to finished biopharmaceutical goods. Our technical expertise allows us to provide effective high quality solutions for our partners biomanufacturing needs. At both our San Diego, California R&D site and our manufacturing site in Yantai, China, MabPlex delivers our commitment to our partners through our quality manufacturing, meeting their expectations.
MabPlex offers one-stop integrated development services including antibody production, linker/cytotoxin synthesis, ADC conjugation process development, and the production of ADC drugs for clinical studies. Additionally, we implement innovative linker technologies to improve the homogeneity, PK/PD and efficacy of ADC drugs. We are fully confident that our services can speed up your ADC development process. MabPlex offers high quality ADC production services through our experienced staff, the state-of-the-art facility, quality by design, and traceable batch records.
Services
MabPlex provides both upstream process development and downstream process development to customers with no existing process or we can redesign and optimize an existing process. In this way, we guarantee that you receive a flawless transfer to scale-up and GMP manufacturing.
Upstream Process Development
Downstream Process Development
MabPlex provides downstream process services for a variety of biologics including monoclonal antibodies, recombinant proteins, complex glycoproteins and ADC products.
MabPlex strives to provide the highest quality monoclonal antibodies to our clients with our proprietary quality management system as a foundation along with our state of the art equipment and facilities. Our mAb generation services utilize hybridoma technologies to create therapeutic antibody candidates. These candidates are selected by various high throughput screening processes. We perform humanization of the murine antibodies to create the humanized therapeutic mAb candidates. Our humanized monoclonal antibody platform allows for rapid expression both in vitro and in vivo evaluation. Based upon our clients’ needs we can create constructs, perform large-scale transient transfections and purify the mAb of interest in milligram to gram scale.
Serum-free cell culture media is one of the key components to manufacturing high quality and high yield antibody therapeutics. At MabPlex, we create multiple high-quality serum-free media and cell culture supplements for process development and GMP manufacturing. Our media are free of serum, protein, and animal-derived components, and are highly suitable for large-scale mammalian cell culture. MabPlex develops cell line-specific medium for each of our clients’ projects in order to maximize antibody drug yield and reduce manufacturing cost. Our media simplifies downstream purification procedures and accelerates drug development processes.
The establishment of a stable cell line is essential for large scale antibody drug production. MabPlex has experience with a broad range of mammalian expression platforms including our own royalty free proprietary platform. We have chosen the industry standard CHO based cell lines, for our cell line development. These cell line platforms allow our customers to reap the benefits of having royalty free, high titers and efficiency to meet timelines for their projects. Relying on our extensive experience and advanced equipment, MabPlex offers high-quality service in accordance with your specific needs.
Cell Line Capabilities
Drug Development Services
Microbiology Services
Protein Modification Services
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