CGMP PRODUCTION
Accommodating your needs from pre-clinical to commercial phases
We assist clients in manufacturing GMP products for cell and gene therapy drugs during clinical trials and commercial stages through the use of our new, state-of-the-art, 160,000m2 (144, 000 sq ft.）GMP facility.
Our technology capabilities and manufacturing capacity are both well recognized and valued by our clients, particularly our ability to provide end-to-end support, including plasmid manufacturing, MCB/MVSS, DS/DP and Fill/Finish. We offer both non-GMP and GMP manufacturing to suit the different needs of our clients at either pre-clinical, clinical, or commercial phases. Our GMP suites include GMO/BSL-2 compliant facilities for live viruses and viral vectors, as well as ISO 5/7 cleanrooms (Grades B and C).
Cell and Microbial Banking
When initiating a cell and gene therapeutic manufacturing program, it is critical to establish quality GMP master cell banks and viral seed stocks as starting materials. Our experience in MCB/MVSS GMP manufacturing empower us to better service our clients. Our teams excel in cell and viral banking, characterization, cloning optimization, and GMP manufacturing.We have extensive cell line experience in HEK293/T, HeLa, SF9, Vero, A549, and more. We offer de novo generation and recovery of infectious virions from plasmid-based systems (virus rescue), as well as genetic characterization, cloning optimization, and seed screening for preliminary infectivity and titer.
Drug substances (DS) and drug product (DP)
We offer both non-GMP and GMP manufacturing for viral vector gene therapy, cell engineering, oncolytic virotherapy, and mRNA DS and DP. All our innovative manufacturing platforms are compliant with international regulatory agencies, including the FDA, EMA, NMPA, etc. We also provide CMC regulatory support for IND and NDA submissions.
When it comes to cell engineering, Porton Advanced has established a robust GMP manufacturing process for both autologous and allogeneic platforms. Currently, we have more than a dozen cell engineering production modules. We offer end-to-end support for both non-GMP and GMP manufacturing from plasmids to lentiviral vectors to cell engineering production.
For viral vector gene therapy, we have built multiple innovative AAV and LVV manufacturing platforms. We offer both HEK293 and SF9 platforms for non-GMP and GMP manufacturing at varying production scales. We have up to ten viral vector gene therapy production suites, enabling us to tailor our approach to the client’s needs in both adherent and suspension systems.
Our newly established mRNA GMP manufacturing modules allow us to offer end-to-end support for GMP RNA manufacturing, including plasmid GMP manufacturing and linearization, mRNA in vitro translations, capping and tailing in USP, multi-step purifications in DSP, and research-grade LNP formulation for fill/finish.
With over a dozen Quality Control (QC) labs, we’re able to offer complete QC assay packages for manufacturing in-process and DS/DP release testing for all gene, cell, and viral therapy products. Our robust QC capabilities and capacities are pivotal to DS and DP manufacturing, which ultimately ensures the patient’s safety and ensures they receive the maximum benefit from treatments.
Fill and Finish
Our high-throughput fill/finish line allows us to produce up to 3,000 vials per hour and 20,000 vials per batch. We can provide fill/finish services to clients based on stand-alone requests, or as part of a broader working package from a project.