AAV pRep/Cap GMP-ReadyTM Plasmids

AAV pRep/Cap provides rep and cap genes for AAV packaging when combined with pHelper and pGOI (gene of interest flanked by ITRs) in triple transfection HEK293 or 293T based AAV production. Vigene offers GMP-Ready (GMP-R) off-the-shelf AAV pRep/Cap2, pRep/Cap5, and pRep/Cap6 for AAV2, AAV5, and AAV6 cGMP production, respectively. This ready-to-use GMP-Ready pRep/Cap is meant to accelerate AAV cGMP manufacturing with a fully documented plasmid with IND filing information and a certificate of analysis (COA).

AAV pRep/Cap GMP-Ready™ Plasmids
CAT# Description Availability Price
GR-PRC2-KAN

AAV pRep/Cap2, GMP-Ready packaging plasmids, providing rep2, cap2 for AAV2 CGMP manufacturing

In stock Please Inquire
GR-PRC5-KAN AAV pRep/Cap5, GMP-Ready packaging plasmids, providing rep2, cap5 for AAV5 CGMP manufacturing In stock Please Inquire
GR-PRC6-KAN AAV pRep/Cap6, GMP-Ready packaging plasmids, providing rep2, cap6 for AAV6 CGMP manufacturing In stock Please Inquire

* MTA needs to be executed before the plasmids can be propagated

Related Products/Services

Production Process of AAV pRep/Cap GMP-Ready Plasmids

Controlled Aspects AAV pRep/Cap GMP-R 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

 

AAV pRep/Cap GMP-R 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

AAV pRep/Cap Plasmids Maps

AAV pRep/Cap is Proven For Efficient AAV Packaging

The robust virus packaging productivity of AAV pRep/Cap plasmids has been tested using the triple plasmids transient transfection method. AAV pRep/Cap plasmids are being used in Vigene’s daily AAV production, for both CGMP grade and research grade batches. Please see the productivity data below.

Fig. 1. pRep/Cap plasmids were tested in AAV production in adherent HEK293 cells. Each serotype specific pRC was cotransfected with the AAV transfer vector and pHelper into HEK293T cells for AAV packaging. The productivity data for each AAV serotype is from individual productions with different AAV transfer vectors containing unique genes of interest. AAV viral vectors were purified via IDX gradient ultracentrifugation. The viral genome titers were measured using qPCR with primers targeting the ITRs.

The Diagram of AAV Production Using the 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 pRep/Cap are cotransfected into HEK293 cells. The AAV transfer vector contains the gene of interest, pHelper plasmid provides Ad helper function genes, and pRep/Cap encodes AAV Rep and Cap.

Need Custom Plasmid Production?

For AAV viral vector packaging, you will also need AAV pHelper plasmid and your pAAV gene-of-interest transfer vector. Vigene has off-the-shelf, premanufactured GMP-Ready pHelper-Kan plasmids, ready for CGMP AAV manufacturing. We can help you with both GMP-Ready and GMP grade plasmid DNA production. Please contact us.

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AAV pRep/Cap provides rep and cap genes for AAV packaging when combined with pHelper and pGOI (gene of interest flanked by ITRs) in triple transfection HEK293 or 293T based AAV production. Vigene offers GMP-Ready (GMP-R) off-the-shelf AAV pRep/Cap2, pRep/Cap5, and pRep/Cap6 for AAV2, AAV5, and AAV6 cGMP production, respectively. This ready-to-use GMP-Ready pRep/Cap is meant to accelerate AAV cGMP manufacturing with a fully documented plasmid with IND filing information and a certificate of analysis (COA).