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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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VIRAL VECTORS - AAV

Technical team dedicated to
AAV process development
and cGMP production

We have a laboratory space of about 4,000 sq mt (43,000 sq ft), which can carry out early R&D, process development, and production of AAV, including upstream (USP) and downstream (DSP) process development, analytical development, and GMP production.

We provide end-to-end AAV gene therapeutic product development, including plasmid manufacturing throughout AAV upstream process development and
downstream process development, and ultimately fill and finish. We offer both mammalian cell HEK293 and insect cell Sf9-based production systems, which provide flexibility to suit every client’s unique needs.

 

Our Services

Based on our professional capabilities, we can provide comprehensive AAV related services:

Two production systems for mammalian cells HEK293 and insect cells SF9
Adherent and levitation upstream process types
Robust process scale-up
● Complete and robust analytical methods ensure the quality of drug substance and finished products
CMC information writing and regulatory submission
Production for investigator-initiated trialsv
Integrated IND-enabling study service
Provide cGMP clinical sample production and NDA submission

AAV PROCESS DEVELOPMENT

Upstream processing

Porton Advanced provides upstream process testing and development to assist customers in optimizing process parameters such as plasmid ratio, cell density, media, transfection reagents, pH, etc. to obtain the best upstream process parameters. We also provide upstream process development services for adherent and suspension production.

Our AAV manufacturing suites can reach a scale of 500L per batch (with a reserved production space of 2000L). Our expertise and collective experience, dedicated process development and analytical development teams, and state-of-the-art facilities and equipment make us a globally leading AAV CDMO.

Downstream processing

Our downstream process development teams can perform a variety of serotypes of AAV purification while supporting both column chromatography and ultracentrifugation. The optimization of the purification process involves various processes such as cell lysis, clarification, ultrafiltration concentration, affinity chromatography, ion exchange chromatography, sterilization and filtration, and formulation development, to obtain adeno-associated viruses with high purity, good activity, and low residue of impurities such as HCP/HCD, and to comprehensively consider production and process costs to confirm the optimal process parameters and purification route.

CGMP AAV PRODUCTION

From Pre-IND to commercial prodution

Porton Advanced has a dedicated viral vector production team with decades of hands-on and management experience.

We have established SF9 and HEK293 system processes, with a maximum capacity of 80 batch/year. The cGMP facility has an independent air conditioning system, a single-use and fully enclosed aseptic production process, and a unidirectional flow of personnel and logistics to minimize the risk of contamination and cross-contamination. The whole production operation can be monitored by CCTV, which can be preserved for further traceability, and all the production equipment has completed CSV (Computerized Systems Validation). The facility design and quality system meet the requirements of cGMP production management systems in China, the US, and the EU, allowing us to provide CDMO services for global clients.

Biosafety level-2

Three independent AAV production lines with a C+A environment and maximum batch size of 500L

Three dedicated cell banking lines with a C+A environment

One isolated fill-finish automated production line with 12,000 vials per batch

Support HEK293 and SF9-based AAV Production