An image of a surgeon in an operating room.

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

A row of white machines in a room.

Cell Engineering

We support both autologous and allogeneic cell engineering

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.

A person in blue gloves is holding a machine.

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
automatic system or integrated units in a class B cleanroom environment
Testing services for drug substance (DS) and drug product (DP)
CMC information writing and regulatory submission
Integrated IND-enabling Study Service
A group of people working in a laboratory.
PROCESS DEVELOPMENT FOR CELL THERAPY

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.

Add Your Heading Text Here

CGMP CELL THERAPY 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.

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 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 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.

CDMO Services for Investigational New Drug (IND) Applications and Clinical-Trials

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.

Add Your Heading Text Here