Information
75 Rue Marguerite Perey, 67400 Illkirch-Graffenstaden, France
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Overview
- Summary
- Polyplus, a part of Sartorius, is a leading upstream solutions provider for advanced biologics, cell, and gene therapy production from research to commercial scale.Polyplus, a part of Sartorius, is a leading upstream solutions provider for advanced biologics, cell, and gene therapy production from research to commercial scale.
- Key Products/Technologies
- FectoVIR-AAV is a high-performance transfection reagent for adeno-associated virus (AAV) production, offering superior productivity and industrial scalability, available in GMP grade.FectoVIR-AAV is a high-performance transfection reagent for adeno-associated virus (AAV) production, offering superior productivity and industrial scalability, available in GMP grade.
- FectoVIR-LV is a next-generation, animal component-free transfection reagent optimized for lentiviral vector production in HEK-293 cell systems, designed for large-scale manufacturing with reduced complexation volume and enhanced complex stability.FectoVIR-LV is a next-generation, animal component-free transfection reagent optimized for lentiviral vector production in HEK-293 cell systems, designed for large-scale manufacturing with reduced complexation volume and enhanced complex stability.
- PEIpro is the gold standard PEI-based DNA transfection reagent for scalable viral vector production (AAV, LVV, and others), offered in three quality grades (PEIpro, PEIpro-HQ, PEIpro-GMP) for a seamless transition from process development to commercialization.PEIpro is the gold standard PEI-based DNA transfection reagent for scalable viral vector production (AAV, LVV, and others), offered in three quality grades (PEIpro, PEIpro-HQ, PEIpro-GMP) for a seamless transition from process development to commercialization.
- in vivo-jetPEI is a ready-to-use cationic polymer reagent for in vivo delivery of DNA, siRNA, miRNA, shRNA, and other oligonucleotides in various animal models, with preclinical and cGMP grades available for clinical trials.in vivo-jetPEI is a ready-to-use cationic polymer reagent for in vivo delivery of DNA, siRNA, miRNA, shRNA, and other oligonucleotides in various animal models, with preclinical and cGMP grades available for clinical trials.
- jetOPTIMUS is an innovative cationic nanotechnology for high DNA transfection efficiency in hard-to-transfect adherent cells, suitable for co-delivery of multiple plasmids and small-scale virus production.jetOPTIMUS is an innovative cationic nanotechnology for high DNA transfection efficiency in hard-to-transfect adherent cells, suitable for co-delivery of multiple plasmids and small-scale virus production.
- The LipidBrick Library is a novel range of proprietary cationic lipids for LNP (Lipid Nanoparticle) formulation, specifically for mRNA-based vaccines and therapeutics.The LipidBrick Library is a novel range of proprietary cationic lipids for LNP (Lipid Nanoparticle) formulation, specifically for mRNA-based vaccines and therapeutics.
- Custom plasmid vector design and manufacturing services include tailor-made DNA plasmid design using innovative assembly technology and powerful algorithms, alongside plasmid manufacturing capabilities in Research, HQ, and GMP grades.Custom plasmid vector design and manufacturing services include tailor-made DNA plasmid design using innovative assembly technology and powerful algorithms, alongside plasmid manufacturing capabilities in Research, HQ, and GMP grades.
- Viral vector Design of Experiment (DOE) service provides expert technical support for optimizing customer processes.Viral vector Design of Experiment (DOE) service provides expert technical support for optimizing customer processes.
- Core Advantages
- Provision of comprehensive upstream solutions for advanced biologics, cell, and gene therapy production, spanning from research to commercial scale.Provision of comprehensive upstream solutions for advanced biologics, cell, and gene therapy production, spanning from research to commercial scale.
- Long-standing innovation in nucleic acid delivery, maintaining a robust portfolio of transfection reagents and services.Long-standing innovation in nucleic acid delivery, maintaining a robust portfolio of transfection reagents and services.
- Availability of GMP-grade products (e.g., FectoVIR-AAV, PEIpro, in vivo-jetPEI) manufactured in compliance with ICH Q7 GMP part II guidelines, ensuring high quality, traceability, and regulatory documentation.Availability of GMP-grade products (e.g., FectoVIR-AAV, PEIpro, in vivo-jetPEI) manufactured in compliance with ICH Q7 GMP part II guidelines, ensuring high quality, traceability, and regulatory documentation.
- Product designs focused on industrial scalability, leading to improved process economics, increased batch yields, and reduced manufacturing costs for viral vectors.Product designs focused on industrial scalability, leading to improved process economics, increased batch yields, and reduced manufacturing costs for viral vectors.
- Integration with the Sartorius Group, fostering synergies with Sartorius's cell culture media and downstream solutions for optimized total process workflows.Integration with the Sartorius Group, fostering synergies with Sartorius's cell culture media and downstream solutions for optimized total process workflows.
- A strong intellectual property portfolio, including numerous patents and patent applications related to nucleic acid delivery technologies such as FectoVIR-AAV, LipidBrick, STICKY SIRNA, and ZNA.A strong intellectual property portfolio, including numerous patents and patent applications related to nucleic acid delivery technologies such as FectoVIR-AAV, LipidBrick, STICKY SIRNA, and ZNA.
- Target Industries
- Cell and Gene Therapy Development and Production IndustryCell and Gene Therapy Development and Production Industry
- Biopharmaceutical Research and Production IndustryBiopharmaceutical Research and Production Industry
- Vaccine Development and Production Industry (especially mRNA-based vaccines)Vaccine Development and Production Industry (especially mRNA-based vaccines)
- Life Sciences Research Sector (basic research, drug discovery and development)Life Sciences Research Sector (basic research, drug discovery and development)
- Protein Production IndustryProtein Production Industry
- Cancer Therapy and other Infectious, Immunological, and Allergic Disease Treatment FieldsCancer Therapy and other Infectious, Immunological, and Allergic Disease Treatment Fields
- Major Markets
- China, India, Japan, South KoreaChina, India, Japan, South Korea
- France (headquarters), Belgium, Switzerland, United Kingdom, European Union (EM)France (headquarters), Belgium, Switzerland, United Kingdom, European Union (EM)
- United States, CanadaUnited States, Canada
- Certifications/Patents
- ISO 9001 Quality Management System Certification (since 2002).ISO 9001 Quality Management System Certification (since 2002).
- Manufacturing compliance with ICH Q7 GMP part II guidelines (for FectoVIR-AAV, PEIpro, etc.).Manufacturing compliance with ICH Q7 GMP part II guidelines (for FectoVIR-AAV, PEIpro, etc.).
- cGMP grade in vivo-jetPEI manufacturing according to US (21CFR parts 210 and 211) and EU Guidelines (Eudralex Vol 4).cGMP grade in vivo-jetPEI manufacturing according to US (21CFR parts 210 and 211) and EU Guidelines (Eudralex Vol 4).
- Independent patent protection for the unique structure of FectoVIR-AAV.Independent patent protection for the unique structure of FectoVIR-AAV.
- Independent patent protection for the unique structure of LipidBrick.Independent patent protection for the unique structure of LipidBrick.
- US Patent No. 8,802,640, European Patent No. 1,888,749, and foreign equivalents for STICKY SIRNA.US Patent No. 8,802,640, European Patent No. 1,888,749, and foreign equivalents for STICKY SIRNA.
- US Patent Nos. 9,090,648 and 8,465,920, European Patent Nos. 1,973,927 and 2,225,393, and foreign equivalents for ZNA® (Zip Nucleic Acids) and Spermine phosphoramidite.US Patent Nos. 9,090,648 and 8,465,920, European Patent Nos. 1,973,927 and 2,225,393, and foreign equivalents for ZNA® (Zip Nucleic Acids) and Spermine phosphoramidite.
- US Patent No. 8,399,422 and Publication No. 20100048672 for compositions for transfection of oligonucleotides active for gene silencing and their biological and therapeutical applications.US Patent No. 8,399,422 and Publication No. 20100048672 for compositions for transfection of oligonucleotides active for gene silencing and their biological and therapeutical applications.
Introduction
Location
75 Rue Marguerite Perey, 67400 Illkirch-Graffenstaden, France
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