Protalix is harnessing the power of cultivated plant cells to express biologically enhanced therapeutic proteins to tackle unmet needs for rare diseases. Protalix advances its products from concept to market using enzyme replacement therapy (ERT) using recombinant protein technology combined with protein enhancement modifications.
This innovation has successfully produced two FDA-approved plant cell expressed biotherapeutics for human use, via Protalix’s ProCellEx® platform including Elelyso® an innovative enzyme replacement therapy (ERT) for patients with type I Gaucher disease and Elfabrio® an innovative ERT for adult patients with Fabry Disease.
Protalix collaborates with Pfizer Inc. and Chiesi Global Rare Diseases. Learn more about collaborating with Protalix.
Therapeutic protein candidate
selection
Disease and target selection based on known mechanism of action
Selection of protein sequence and optimization to pursue a therapy with high efficacy and stability
Genetic engineering of plant cells
Development and implementation of advanced technologies for expression in plant cells including plant viral systems
Establishment of improved platform cell lines suitable for different and diverse requirements such as glycosylation, proteolysis, and others
Protein modification optimization
Design and development of chemical modifications, like PEGylation to improve physiochemical and biological properties for optimal clinical profiles
Pilot production with the
ProCellEx® platform
Development of protein purification process and drug formulation
Development of analytical methods to support process development and drug characterization
Scale up to pilot production facility for pre-clinical and clinical studies
Preclinical and clinical development
Design and execute pre-clinical trials and clinical trials to establish proof of concept
Continue clinical development to Phase III to support submission for marketing approval
Commercial production
Scaling up the cell suspension including downstream purification process and GMP validation to produce large quantities of the therapeutic protein to support advance clinical stages and commercial needs
Marketing approvals
and commercialization
Meeting the rigorous demands of regulatory agencies, identifying and collaborating with commercialization partners
