Powered by innovation, we have established expertise across a broad range of cell and gene therapy platforms:
Today, cell therapy is one of the most successful applications of advanced medicine. Porton Advanced offers both autologous and allogeneic cell therapy platforms.
In autologous cell therapy,
T cells are collected from the individual patient. This includes CAR-T, TCR-T, TIL, etc.
In allogeneic cell therapy,
Cells are obtained from healthy donor pools, such as UCAR-T, NK, stem cells, IPSCs, etc.
We offer our customers integrated support, including process development, analytical development, cGMP manufacturing, research support, testing services, and regulatory assistance.
Thanks to our extensive experience and expertise, we are able to offer a complete, end-to-end service for cell therapy development and manufacture:
We have around 40,000ft2 of laboratory space and R&D and process science teams dedicated to AAV development and manufacturing, including upstream process (USP) and downstream process (DSP) development, analytical development and DS/DP GMP manufacturing.
We provide discovery research, end-to-end AAV gene therapeutic product development, including plasmid manufacturing throughout AAV USP and DSP for DS, and ultimately DP 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.
Based on our capabilities and capacity, we are able to offer a broad portfolio of AAV services:
We support design of experiments (DOE) to help clients optimize manufacturing process parameters such as MOI ratio, media, cell density, pH, CO2 etc. to develop a robust and productive AAV upstream process. Our teams have great experience working with different AAV serotypes.
Our AAV manufacturing suites are equipped to offer up to 2000L capacity. Our expertise and collective experience, dedicated PD and AD teams, and state-of-the-art facility and equipment make us a globally leading AAV CDMO.
A lentivirus is a single-stranded RNA retrovirus that is widely used as a gene transfer tool in cell and gene therapies based on their ability to infect both dividing cells and differentiated non-dividing cells.
raditionally, lentiviral vectors (LVVs) are manufactured using an adherent cell production system with serum, but serum-free suspension cell systems have also been developed as an alternative. At Porton Advanced, we have developed a proprietary suspension HEK293T LVVs production system (PTLV-SMART) Figure 4 , which through cell line clonal screening, suspension adaptation, as well as assessment of viral packaging. Our innovative system has been successfully used in over a dozen of our clients’ projects at our facility.
We also offer other commercial LVV suspension production systems, according to our clients’ requests and needs, and we have successfully supported several of our clients in filing Investigational New Drug Applications (INDs).
We offer the following LVV services, which uniquely position us to support our cell therapy clients:
By integrating our LVV platform, we are able to provide an end-to-end service to cell therapy clients, spanning from DNA plasmid discovery research and GMP manufacturing, to LVV manufacturing process development and GMP manufacturing, and finally to cell therapy DS and DP production.
mRNA is a promising and rapidly growing new class of advanced medicine, based on the speed of manufacture, ability to encode varied proteins, excellent safety and efficacy profile, and flexibility in modality and formulation.
We are a trusted partner to our clients, providing end-to-end services that reach from plasmid process development through to GMP mRNA manufacturing:
After co-transcription capping and tailing, mRNA yield can reach 5mg/ml.
Lanes 3 and 6 show LNP packaged mRNA, which is too large to move into the agarose gel. Lanes 4 and 7 show mRNA bands after lipid coating dissolved using Triton X-100.
Oncolytic viruses (OVs) are another promising therapeutic modality, which show great potential in treating many different types of cancers. Due to the large number of different oncolytic viruses, development and manufacturing must be specific and tailored to the individual needs of our clients. This demands a high level of understanding of the virus sciences and manufacturing technologies.
At Porton Advanced, we produce oncolytic viruses starting from the viral infection of VERO, A549 or HEK293 cells. Our teams specialize in cell line banking, viral seed stocking, and large-scale viral production. For example, we have a great deal of experience working with the adherent culture system that most OV production relies on.
Porton Advanced provides a full range of CDMO services for oncolytic virus, providing flexibility in cell lines, virus seeds, adherent and suspension systems, cleanroom B and aseptic processes, etc.:
We also have a dozen Class B cleanrooms, which allow us to perform aseptic manufacturing on a daily basis.
As a carrier of target genes, plasmids have significant impact on the quality, safety and effectiveness of the gene and cell therapy final products.
Our teams have years of proven experience in plasmid manufacturing, including construct optimization, colony selection, and GMP manufacturing process and analytical development. We understand the importance of lowering the production cost without compromising the quality, safety and effectiveness of the final CGT products.
Our expertise in plasmid development and manufacturing includes:
In the upstream process it is necessary to maximize the productive yield, while in the downstream process it becomes critical to remove any impurities, including host cell DNA (HCD), host cell protein (HCP), and safety contaminants such as endotoxin, bacteria and exogenous virus Figure 8.