Powered by innovation, we have established expertise across a broad range of CGT platforms:
Today, cell engineering is one of the most successful a pplications of advanced medicine. Porton Advanced offers both autologous and allogeneic cell engineering platforms with integrated supports including CRO service, process development, analytical development, cGMP manufacturing, testing services, and regulatory assistance.
In autologous cell engineering,
T cells are collected from the individual patient. This includes CAR-T, TCR-T, TIL, etc.
In allogeneic cell engineering,
Cells are obtained from healthy donor pools, such as UCAR-T, NK/CAR-NK, γδ T, red cells, MSC, IPSCs, etc.
Thanks to our extensive experience and expertise, we are able to offer a complete, end-to-end service for cell engineering development and manufacturing:
Porton Advanced has developed a mature process platform and has accumulated rich CMC experience for different types of cell engineering. At the same time, we continue to invest resources in optimization and development of new process technologies to meet the needs and challenges of industry development.
Porton Advanced has established numerous types of cell engineering-related processes and platforms. Our team can deliver, with efficiency and high-quality, various types of customized products.
Independent cell engineering suites for donors with infectious disease
Porton Advanced has successfully obtained clinical approval for 8 IND applications since the launch of our first cell engineering cGMP production line back in 2020. We now provide CDMO services for dozens of cell engineering projects at varying stages such as investigator-initiated trials, preclinical trials, IND applications, clinical trials, and more. So far, Porton Advanced has 12 independent production lines, which allows us to simultaneously produce autologous cell products, allogeneic cell engineering products, and cell engineering products with more closed operations.
● Allogeneic cell engineering production line: equipped with high-volume separation, cultivation, concentration, and filling equipment. Each line has one class B+A clean room and multiple class C operating rooms.
● Autologous cell engineering production line: equipped with automated separation, cultivation, and concentration equipment. Each line has one class B+A clean room and several class C operations rooms.
● There are also several production lines designed to serve more closed operations: multiple class C operating rooms with Class A isolators.
● Independent cell engineering suites for donors with infectious disease: each line has one Class B operating room and multiple class C operating rooms.
● Auxiliary room features: automatic filling room with multiple B+A liquid dispensing rooms and multiple C+ isolators. Equipped with an IPC intermediate product control room, feeder cell irradiation room, sterilization room, inactivation room, material temporary storage room, Kitting sorting room, etc.
● All cGMP workshops have independent air conditioning systems.
● Compliant and uni-directional flow of personnels, logistics, products, and waste.
Porton Advanced provides three-tiered cell banking services (cell lines including MSC, k562, etc.) based on adhesion and suspension processes. Our technical team will establish a three-tiered cell bank in a cGMP environment and perform programmed cooling and cryopreservation to maximize cell viability.
● Obtained clinical approval for several IND applications
● Offering CDMO services for multiple projects at phase I/II
Our cGMP facilities at the Mulberry Field Island campus and the Ascendas Park campus both are in compliance with NMPA, FDA, and EMA regulations. We will work together with clients to apply for a drug production license at the clinical trial stage II for BLA application.