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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

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

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

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

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

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

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

Marketing approvals
and commercialization

Meeting the rigorous demands of regulatory agencies, identifying and collaborating with commercialization partners