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CAR Cell Therapy Manufacturing

Chimeric antigen receptor (CAR) cells have been a promising and breakthrough cancer therapeutic strategy which holds great potential; with CAR-T and CAR-NK cells leading the way. CAR cells are genetically modified immune cells specifically equipped and enhanced to target disease indications such as cancer.

At uBriGene, we have highly trained and experienced personnel in CAR cell production with over 100 CAR-T batches prepared. Our cell therapy manufacturing is performed in Grade A fully closed isolator systems. Single-use production processes in dedicated suits and lots for individual patients are used to prevent cross-contamination. We currently have 12 fully operational cell therapy manufacturing suits for production.

Production Workflow

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Immune cells are recovered from the patient and isolated. Once the preferred cell type is purified, the desired immune cells are targeted for receptor modification and editing in our clean room suits. Following expansion to the desired quantity, the CAR cells are aseptically packaged a ready for patient infusion.

Production Technique Highlights

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Matured Technology and Experience

Highly experienced and established technology with over 100 batches of CAR cell production to date.  

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GMP Cleanroom Design

C+A cleanroom design with absolute Grade A isolators.

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Fully Enclosed Isolators

Custom-made fully enclosed Grade A production environment.

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Sterility Control
 

Dedicated and enclosed cell manipulation and handling systems prevent cross-contamination of products.

Quality Control and Assurance

With our one-stop shop solution to our client’s cell and gene therapy needs, we provide the highest quality QA and QC support. Our dedicated and experienced quality teams assist our clients in developing testing methods to meet even the most stringent requirements of GMP projects.

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Clinical Studies

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Case 1: Mr. Li
Male, 20 years old. Symptoms onset in 2015. 

Clinical Diagnosis: Refractory relapsed Hodgkin’s lymphoma, CD30 positive.

Treatment: Autologous anti-CD30 CAR-T cell therapy.

Clinical Efficacy: Complete remission 1.5 years post infusion. Patient returned to high quality of life 2 years after completion of CAR-T cell treatment regime.   

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Case 2: Ms. Fan
Female, 47 years old, Symptoms onset in July 2017.

Clinical diagnosis: Refractory relapsed Hodgkin lymphoma, CD30 positive.

Treatment: Autologous anti-CD30 CAR-T cell therapy.

Clinical efficacy: Patient in remission 2.5 months post infusion initiation with PET-CT scans showing complete dissipation in 2018. Patient had no adverse reactions to treatment such as cytokine storm or neurotoxicity. Patient has return to normal and high quality of life.

  • Why is a three-tiered cell bank required?
    According to regulations, a complete culture cell bank must be established before GMP-grade plasmid production, including the primary cell bank, the master cell bank and the working cell bank.
  • What is the storage temperature for plasmids? How long can they be stored?
    According to BriGene’s many years of GMP plasmid production experience, the storage temperature of plasmids is -20°C, and the long-term storage stability data can be traced back for more than half a year.
  • Which strain is used to produce plasmids?
    uBriGene uses DH5α or Stbl3 for plasmid production, depending on the customer's choice.
  • Why are plasmids modified for kanamycin resistance?
    Regulations require that the vectors used in gene therapy drugs must not introduce resistance to penicillin.
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