MabPlex

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

• Cytotoxin development and GMP synthesis
• Linker development and GMP synthesis
• Linker and cytotoxin conjugations
• Process development and optimization of ADC conjugation
• Scale up of ADC conjugations to 20L, 100L or up to 500L volumes (g to kg scale)
• Process development for ADC formulation
• ADC product filling/finishing
• Antibody production and optimization for ADC drugs
• Stability studies for ADC products
• Characterization of ADC products

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

• Optimization of the bioreactor processing
• Extensive experience with CHO DG44 and CHO K1 mammalian cell types
• High cell density and titer optimization with mammalian cells
• Development of custom media and feed
• Bench-scale up process characterization
• Validation of ADC products

Downstream Process Development

MabPlex provides downstream process services for a variety of biologics including monoclonal antibodies, recombinant proteins, complex glycoproteins and ADC products.

• With our one-stop offering from cell line development to commercial production, we can move quickly and predictably, providing a smooth transition from late process development into a product’s manufacturing phase. Our experience also allows us to develop more customized approaches to meet our customers’ needs.
• We optimize our downstream processes to remove impurities, therefore providing optimal recovery and manufacturing.

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.

• Chemically defined medium development
• Customized platform for medium development on various requirements
• Analysis platform for medium component consumption
• GMP production of chemically defined medium

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

• Experience in expression systems including our own proprietary expression platform
• High efficiency plasmid transfection
• High-throughput screening of cell clones
• Clone selection selected on quality and high titer
• Customized cell culture media
• Evaluation of antibody yield in scaled-down model
• Evaluation of cell line stability
• GMP cell banking including MCB and WCB
• Exceptional expression amounts appropriate for commercial production

Drug Development Services

Microbiology Services

Protein Modification Services