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CDMO SERVICES

Broad and extensive expertise

Powered by innovation, we have established expertise across a broad range of CGT platforms:

Cell Engineering

Autologous, Allogeneic

Viral Vectors

Lentiviral vector
Adeno-associated viral vector

mRNA

mRNA drug substance Formulated drug product

Plasmid

Supercoiled plasmid
Linear Plasmid
DNA Vaccine

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Our Services

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LENTIVIRUS PLASMID PRODUCTION

Lentiviral Helper Plasmids​

Porton Advanced has completed numerous GMP productions of plasmids, including supercoiled plasmids for Lentivirus, Adeno-Associated Virus (AAV), and linearized plasmids for mRNA.

Our facilities are equipped with level D cleanrooms for upstream fermentation, level C cleanrooms for downstream purification, and level B cleanrooms for the filling area.

Additionally, we offer ready-‐to use lentiviral helper/packaging plasmid products that have been registered with the FDA Center for Biologics Evaluation and Research (CBER) and also meet the requirements of both China National Medical Products Administration (NMPA) and European Medicines Agency (EMA):

P003-LV-SMART™ VSV-G (FDA Drug Master Files (DMFs) #29485)
P002-LV-SMART™ Rev (FDA Drug Master Files (DMFs) #29473)
P001-LV-SMART™ GagPol (FDA Drug Master Files (DMFs) #29421)

(P001, P002, & P003 plasmids have assisted multiple cell engineering projects).

Off-The-Shelf Product: Three Helper Plasmids for Lentivirus Production

Porton Advanced provides off-the-shelf lentiviral helper plasmids accelerating the project development process from clinics. P001, P002, and P003 plasmids have assisted multiple cell engineering projects to obtain China NMPA IND approvals and the corresponding Drug Master Files (DMFs) have been successfully received by FDA.

These three helper plasmids have built master cell banks (MCB), as well as working cell banks (WCB). Porton Advanced can provide off-the-shelf products and Chemistry Manufacturing and Controls (CMC) information, which ultimately shortens the project cycle. When using the lentiviral helper plasmids for clinical and marketing applications of CGT products in the US market, customers can directly cite the FDA DMF numbers and refer to the Letter of Authorization (LOA) provided by our team.

DRUG MASTER FILE ACKNOWLEGEMENT: