PEIpro?-GMP
Viral vector for Gene & Cell Therapy
The highest quality grade for therapeutic virus production
Trusted reagent: Highest quality reagent on the market produced by the leader in transfection for gene therapy
Qualified: GMP-compliant raw material for Human Advanced Therapy Medicinal Product (ATMP) manufacturing
Flexible and cost-efficient: Available in several bottles and bags conditioning with MPC connectors and weldable tubing
Reproducible: Guaranteed virus production yields equivalent to PEIpro® and PEIpro®-HQ
Overview
Specifications
|
Reagent |
PEIpro®-GMP |
|
Concentration |
1 mg/mL |
|
Molecule delivered |
Plasmid DNA and co-delivery of several plasmid DNA |
|
Applications |
Large scale virus production for clinical trials and commercialization |
|
Virus types |
Mainly adenovirus, Adeno-Associated Viruses (AAV), Lentiviral Vector (LV), influenza virus, retrovirus, Virus-Like Particles (VLP) |
|
Cell types |
Mammalian producer cell lines (HEK-293, HEK-293 derivatives, BHK, VERO cell lines, virus-specific packaging cell lines) grown in adherent or suspension cultures |
|
Number of transfections |
1 L of PEIpro®-GMP is sufficient to transfect on average 500 L of cell culture |
|
Storage |
5 ± 3°C, 2 years from manufacturing date |
|
Provided with |
Certificate of Analysis |
|
Regulatory documentation available upon request |
DMF (Drug Master File) on file (FDA) |
Summary
Qualified raw material for therapeutic viral vector production: PEIpro®-GMP is manufactured in compliance with EU “Guidelines of good manufacturing practice for medicinal products for human and veterinary use” (ICH Q7 and EudraLex Vol 4, Part II and Annex I).
Flexibility and cost-efficient for viral vector platforms: PEIpro®-GMP is the highest quality grade PEI and only transfection reagent available on the market supplied in single-use bags and in polypropylene (PP) bottles for manufacturing of therapeutic viral vectors.
Reliability in viral vector infectious titer: Smooth transition from initial process development to large scale manufacturing of therapeutic viral vectors. Transfection protocols established with PEIpro® and PEIpro®-HQ are guaranteed to be directly transferable when moving on to PEIpro®-GMP to produce therapeutic viral vectors for late phase clinical trials and commercialization.
Ordering information
|
Reference Number |
Amount of reagent |
|
125-01L |
1 L bag |
|
127-300 |
300 mL bag |
|
126-100 |
100 mL bottle |
|
126-10x10 |
10 x 10 mL bottles |
Qbtest? X-Green II 双链 DNA 定量试剂盒
Dualucif? 双荧光素酶报告基因检测试剂盒
RTU (Ready-to-Use) 速溶颗粒
Super Gelblue? 核酸染料&GelstainRed? 核酸染料
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