Check the complete process of starting
CAR T-Cell therapy in your hospital.
How it works?
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Training
Comprehensive training of biotechnicians, paramedic staff and clinicians.
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Laboratory Set UP
Will build state of the art biotechnology laboratory with the best quality standards.
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Tech Transfer
Will start with vector supply and will slowly transfer the technology to enable self-reliance.
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Infusion
Start CAR T cell development and infusion in your facility.
Benefits
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Affordable CAR T Cell therapy
Local manufacturing will bring down the cost of CAR T-Cell therapy to a great extent, ensuring affordability for patients.
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Centre of Excellence
The introduction of CAR T-Cell therapy would position the hospital as a leading center for innovative cancer treatment in Iran.
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Revenue
Starting CAR T-Cell therapy will add an additional revenue stream to the hospital, resulting in higher profits.
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Well-Being
Locally grown CAR T results in better patient outcomes as quality control is much better.
Time Lines
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Training (3-6 Months)
Comprehensive training of biotechnicians, paramedic staff, and clinicians.
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Laboratory (1-6 Months)
Will build a state-of-the-art GMP-compliant laboratory with all the quality standards.
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Tech Transfer (1-6 months)
Will start with vector supply and will slowly transfer the technology to enable self reliance.
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CAR T Infusion (8th month)
Start CAR T cell development and infusion in your facility.
CAR T-Cell Therapy PROCESS
Sample extraction: Patient peripheral blood is obtained.
Sample testing: After the sample source meets the quality standards, enter the Grade C clean workshop for purification.
PBMC isolation: PBMC was isolated from peripheral blood
T cell sorting and activation: Nanomagnetic beads were applied to separate and activate T cells in the PBMC.
Lentiviral transduction: CAR T cells were prepared by transduction of the corresponding titer of T cells.
Sample testing: Samples are tested for microorganisms, lentiviral transduction rate, and cell subsets during culture.
Sub-amplification: Cells were sub-amplified and generally cultured between Day10 - Day14.
Preparation: The qualified cells are configured as biological agents, and they will be distributed to clinical practice after all the quality inspection meets the standards.
Technology Transfer Package
Chemistry, manufacturing, and quality control of CD19-CAR and BCMA-CAR-modified autologous T cell production under GMP standards.
Chemistry, manufacturing, and quality control of CD19-CAR and BCMA-CAR-related DNA plasmids under GMP standards.
Chemistry, manufacturing, and quality control of CD19-CAR and BCMA-CAR lentiviral vectors under GMP standards.
Preparation stage:
Machinery and plant equipment designs
Facility/equipment specifications and capabilities
Bio hazard level and personal protection procedure
Equipment list for manufacturing processes and laboratory apparatus, including special instruments for analysis.
Piping and instrumentation diagrams (P&IDs) for equipment that may be specific to the process.
Requirements for particular sensors or analytical equipment where differences in types (sensitivity, methodology, etc.) or suppliers may result in skewed measurements or equipment.
List of raw materials with name of manufacturer and catalogue numbers.
Buffer compositions used in the BPCR.
List of manufacturing accessories (such as filter type).
Materials:
1. Safety data sheets of raw material and Products
2. Bill of materials for the Process
3. Media and buffer formulations
4. Other materials/consumables, e.g., filters, bags, gaskets/O-rings, tubing, sieves for sifters,
screens for milling
CAR T Development
Cell Bank Installation
Process and laboratory equipment User Requirements Specifications
Release Specifications (Drug Substance Release)
Process Overview Description
Assays are required to support early activities such as process bench marking at a small scale.
Cleaning procedure
Cleaning Development studies, validation reports, and/or recommendations for any difficult-to-clean residues from each step in the process.
Materials of construction, compatibility studies for process materials, and solutions.
Specifications, Method of Analysis and Standard Operating Procedures for Raw materials (other than Pharmacopoeia)
Manufacturing Stage:
Process Flow Diagrams (PFDs), e.g., processing times, in-process testing PFDs from all previous installations of the process (different sites or scales).
Standard Operating Procedures and details of Manufacturing Process and Formulation.
Operation Instructions and Data
Media Fill Protocol
Cleaning Validation Protocols and Records and Standard Operating Procedures
Executed Batch Process Control Record (BPCR) for Drug Substance
Quality Control
Specifications, Method of Analysis, and Standard Operating Procedures for Raw Materials (other than Pharmacopoeia).
Specifications, Technical Data Sheets and Certificates of the Reference Standards related to Raw Materials, Finished Products and Impurities.
Release Specifications (Drug Product Release)
Process information
Automation/Process Control Requirements
Process Validation Protocols and Reports
In-Process Quality Control Specifications (IPQC)
Product/Process safety assessments include information on requirements for personal protective equipment (PPE), exposure limits, containment requirements, or hazardous waste disposal for materials specific to the process.
Cleaning Validation Protocols and Records and Standard Operating Procedures.
Quantity of MCB and WCB required
MCB and WCB verification index, method and result
Physico-chemical characterization of the drug substance details and methods.
Analytics used on the Manufacturing floor for supporting shakedown and subsequent runs
Equipment User Requirements Specification (URS) and/or Functional Requirements Specification (FRS).
Information on hazardous waste or other waste streams that may require special disposal or neutralization consideration.
Complete list of equipment and materials required to establish a CAR T Cell therapy lab.
Please email us care@beijingbiotech.com to get the complete list of equipments and materials required to establish a CAR T Cell therapy lab.
