Cell Engineering CMC/IIT/IND

Cell Engineering

We support both autologous and allogeneic cell engineering

Today, cell engineering is one of the most successful applications 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.

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Our Services

Thanks to our extensive experience and expertise, we are able to offer a complete, end-to-end service for cell engineering development and manufacturing:

Research-grade cell engineering production

Process development, optimization, scale-up and scale-out

Analytical method development and optimization, analytical method qualification and validation

Cell production for investigator-initiated trials and clincial-trials

cGMP manufacturing in either a fully closed

Testing services for drug substance (DS) and drug product (DP)

MC information writing and regulatory submission

Integrated IND-enabling Study Service

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PROCESS DEVELOPMENT FOR cell engineering

Support of over 11 types of cell engineering

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.

Process platforms dedicated for different types of cell engineering

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.

Closed system for PBMC apheresis from healthy/patient donor
Manufacturing process for fresh and freezing PBMC
Raw Material selection (including china vendor replacement)
Multiple viral vector transduction processes and optimal solution selection
Closed electrophoresis system for gene editing (including china vendor replacement)
Closed expansion system of XuriWAVE, G-Rex, and culture bag
Closed system for cell harvest and purification (including large-scale manufacturing)
Formulation, cryopreservation, and fill–finish for frozen drug products
Independent cell engineering suites for donors with infectious disease

MSC separation processes from different tissue source (including fat, umbilical cord, placental tissue, bone marrow tissue, etc.)
Autologous and allogeneic cell engineering processes
Material selection (including China vendor replacement)
Lentiviral vector transduction process (optional)
Expansion process in cell factory/ super cell factory
cGMP cell banking process
Closed system for cell harvest and purification (including largescale manufacturing)
Formulation, cryopreservation, and fill–finish for frozen drug product

Closed separation process for mobilized leukapheresis HSC Material selection (including china vendor replacement)
Stimulation process for HSC
Lentiviral vector transduction process (optional)
Closed system for cell harvest and purification (including largescale manufacturing)
Independent cell engineering suites for donors with infectious disease

TIL separation process from different tumor sources
Material selection (including china vendor replacement)
Feeder cell preparation process
Irradiation process (including china vendor replacement)
Lentiviral vector transduction process (optional)
Closed and rapid TIL expansion process in GRex or XuriWAVE
Closed system for cell harvest and purification (including largescale manufacturing)
Formulation, cryopreservation, and fill–finish for frozen drug products
Independent cell engineering suites for donors with infectious disease

NK culture process from different sources (PBMC, CBMC, etc.)
Material selection (including china vendor replacement)
Separation process for NK cells
Multiple activation processes for NK cells
Feeder and feederfree expansion process
Multiple NK transduction processes (including lentivirus, γretrovirus, electrophoresis)
Serumfree culture process for NK cells
Closed perfusion culture technologies for NK/CARNK cells
Closed cell harvest and purification process for NK/CARNK cells (including largescale manufacturing)
Formulation, cryopreservation, and fill–finish for frozen drug products
Autologous and allogeneic manufacturing processes

Process platforms for multiple cell engineering types

For CAR-T or TCR-T, lentiviral static transduction is usually used without the addition of transduction enhancers. The VCN (Vector Copy Number) of healthy CD3-positive cells is controlled to be no more than 3, and CAR or TCR positive rate is 60~90%.

According to various client request, Porton Advanced designs and explores optimal electroporation proecess for efficiently knock-in/out target genes by numerous electroporation equipment (including Lonza, Thermo, Etta and so on).

To reach specification of cell engineering excipients, Porton Advanced can perform irradiation on feeder cells by our own irradiation equipment.

CGMP cell engineering MANUFACTURING

Supporting from pre-IND to clinical trials

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.

CELL BANKING SERVICE

12 closed system cell engineering cGMP production lines

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

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.

Cell banking workflow

CELL BANKING SERVICE

Qualified for IND/BLA application in China and US

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.