AAV pHelper-Kan

pHelper-Kan, GMP-ReadyTM AAV Helper Plasmids

pHelper-Kan provides adenoviral helper genes, E2A, E4, and VA for AAV packaging when combined with pRep/Cap and pGOI (gene of interest) in triple transfection HEK293 or 293T based AAV production. This ready-to-use GMP-ReadyTM pHelper plasmid is meant to accelerate AAV cGMP manufacturing with a fully documented plasmid with IND filing information and a certificate of analysis (COA).

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pHelper-Kan GMP-Ready™ AAV Helper Plasmid
CAT# Description Availability
GR-PHELPER-KAN

pHelper-Kan, GMP-Ready™ helper plasmid providing Ad helper function for AAV packaging

In stock

Production Process & Release Testing

The GMP-ReadyTM AAV pHelper-Kan plasmid DNA was produced and released according to batch records production (e.g., documentation, material segregation, traceability, etc.). Although GMP-ReadyTM plasmids are not manufactured in a GMP suite, GMP-ReadyTM plasmids are manufactured in dedicated clean-rooms with mandated changeovers before new production cycles.

Production Process of pHelper-Kan GMP-RTM Plasmid

Controlled Aspects pHelper-Kan GMP-RTM Plasmid
Establishment of E. coli master & working cell banks
Full traceability of materials
Full room changeover prior to each production
Production in segregated and dedicated space
Process & change control
Aseptic fill/finish and vialing
Document support for IND and IMPD filing
Master batch records
Product release tests

 

pHelper GMP-RTM Plasmid Release Testing
Safety: Endotoxin, sterility
Identity: Restriction analysis & DNA sequencing
Purity: UV spec, OD260/280
DNA homogeneity: Percentage of supercoiled
Purity: Residual impurities, host cell DNA, host cell RNA, host cell protein
Purity: Cross batch contamination test by Next-Gen sequencing
Documentation

pHelper-Kan Plasmid Map

pHelper-Kan is Proven For Efficient AAV Packaging of Different Serotypes

The robust virus packaging productivity of the pHelper-Kan plasmid has been tested in almost all AAV serotypes. pHelper-Kan is being used in Vigene’s daily AAV production, for both GMP grade and research grade batches. Please see the production data below for AAV2, AAV5, AAV6, AAV8, and AAV9 serotypes.

Fig. 1. pHelper-Kan was used in AAV production in adherent HEK293 cells. pHelper-Kan was cotransfected with the AAV transfer vector and pRepCap into HEK293 cells for AAV packaging. The productivity data for each AAV serotype is from 10 individual productions with different AAV transfer vectors containing unique genes of interest.  The viral genome titers were measured using qPCR with primers targeting the ITRs.

The Diagram of AAV Production Using Triple Plasmid Transfection Method

Fig. 2. AAV virus production using triple plasmid transient transfection method. AAV viral vectors will be packaged and assembled when the AAV transfer vector, pHelper, and pRepCap are cotransfected into HEK293 cells. The AAV transfer vector contains the gene of interest, pHelper plasmid provides Ad helper function genes, and pRepCap encodes AAV Rep and Cap.

Need Custom Plasmid Production?

For AAV viral vector packaging, you might also need Rep-Cap plasmid and your transfer vector with your gene of interest flanked by AAV ITRs. Vigene can help you with both GMP-ReadyTM and GMP grade plasmid DNA production. Please contact us.

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pHelper-Kan provides adenoviral helper genes, E2A, E4, and VA for AAV packaging when combined with pRep/Cap and pGOI (gene of interest) in triple transfection HEK293 or 293T based AAV production. This ready-to-use GMP-ReadyTM pHelper plasmid is meant to accelerate AAV cGMP manufacturing with a fully documented plasmid with IND filing information and a certificate of analysis (COA).