Plasmid DNA and co-delivery of several plasmid DNA
Large scale virus production for pre-clinical and early phase clinical trial
Mainly adenovirus, Adeno-Associated Viruses (AAV), Lentiviral Vector (LV), influenza virus, retrovirus, Virus-Like Particles (VLP)
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®-HQ is sufficient to transfect on average 500 L of cell culture
5°C ± 3°C, 3 years from manufacturing date
Certificate of Analysis
|Regulatory documentation available upon request|
Batch Production Documentation
PEIpro®-HQ is a Highly Qualified version of PEIpro® DNA transfection reagent. Large-scale transfection protocols established with PEIpro® during process development are guaranteed to be seamlessly applicable with PEIpro®-HQ for manufacturing of viral vectors for pre-clinical and early phase clinical trial. To move on to therapeutic viral vector production for late phase clinical trials and in fine commercialization, PEIpro®-HQ should be replaced by PEIpro®-GMP, 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).
|Reference Number||Amount of reagent|
Manufactured according to a well-established process
PEIpro®-HQ is manufactured and formulated using a well-established and controlled manufacturing process (Fig. 1). Each lot of PEIpro®-HQ meets extensive and stringent release specifications to ensure reliable and reproducible supply of remarkably high-quality DNA transfection reagent. Hence, with each lot of PEIpro®-HQ comes a Batch Production Documentation available upon request that comprises the summary of the manufacturing process and Quality Controls.
Fig. 1: Manufacturing process of PEIpro®-HQ reagent
Read the article published in Cell & Gene Therapy Insights: Addressing scaling-up limitations: optimized PEI-mediated production of clinical grade viral vectors
Read the article published in GEN: Simplifying the Efficient Clinical-Grade Production of Viruses
Guaranteed seamless transition from PD to pre-clinical grade virus production
PEIpro® and PEIpro®-HQ and highest quality grade PEIpro®-GMP are exactly the same in terms of chemistry and formulation – all three quality grades can be used with the same protocol to produce identical virus production yields. PEIpro®-HQ differs from R&D grade PEIpro® in that we offer more comprehensive lot-release Quality Controls with stringent specifications and extensive documentation that enable its use as raw material during upscaling of therapeutic viral vector production. During Process Development, it is beneficial to choose raw materials from reliable suppliers that exist at several quality grades to facilitate and accompany transition from Process Development (PD) (PEIpro®) to preclinical-grade virus production (PEIpro®-HQ) up to commercialization(PEIpro®-GMP). For more information on optimal transfection efficiency and virus production yields, see here.
With PEIpro® product range, we have the quality level that meets your needs!
Fully characterized Product with extensive Quality Controls
There is an increase in regulatory scrutiny on raw materials for production of therapeutic viral vectors used in pre-clinical and early phase clinical trial. It has thus become mandatory to meet higher quality levels of raw materials as early as possible during development of ATMPs for their use in pre-clinical and early phase clinical trial. PEIpro®-HQ fully addresses these needs with extensive Quality Controls to assess identity, potency, safety and purity on both bulk material and formulated PEIpro®-HQ. Potency of PEIpro®-HQ is controlled with a standardized transfection assay to ensure reliability and reproducibility of transfection efficiency under optimal conditions for virus production. Safety of PEIpro®-HQ is tested to ensure complete sterility and absence of mycoplasma and very low level of bacterial endotoxins. Purity of PEIpro®-HQ is controlled with an impurity profile, assessment of residual organic solvent and heavy metal content. A comprehensive list of Quality Controls is available upon request .
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