Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 59573
2: Name of authorisation holder CGTC MANUFACTURING INNOVATION CENTRE LIMITED
3: Address(es) of manufacturing site(s)

CELL AND GENE THERAPY CATAPULT MANUFACTURING AND INNOVATION CENTRE, 4 WARNER DRIVE, SPRINGWOOD INDUSTRIAL ESTATE, BRAINTREE, CM7 2YW, UNITED KINGDOM

4: Legally registered address of authorisation holder CGTC MANUFACTURING INNOVATION CENTRE LIMITED, 4 WARNER DRIVE, SPRINGWOOD INDUSTRIAL ESTATE, BRAINTREE, CM7 2YW, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 10/07/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

CELL AND GENE THERAPY CATAPULT MANUFACTURING AND INNOVATION CENTRE, 4 WARNER DRIVE, SPRINGWOOD INDUSTRIAL ESTATE, BRAINTREE, CM7 2YW, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.1 ] Large volume liquids
            Special Requirements
            Live Cells
            Advanced Therapy Medicinal Products
        [ 1.1.1.4 ] Small volume liquids
            Special Requirements
            Live Cells
            Advanced Therapy Medicinal Products
        [ 1.1.1.6 ] Other aseptically prepared products
            Cell and viral vector based Advanced Therapeutic Medicinal Products
            Special Requirements
            Live Cells
            Advanced Therapy Medicinal Products
    [ 1.1.3 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.3 ] Cell therapy products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.1.4 ] Gene therapy products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.1.5 ] Biotechnology products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.1.6 ] Human or animal extracted products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.1.8 ] Other biological medicinal products
            Viral vectors
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.3 ] Cell therapy products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.2.4 ] Gene therapy products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.2.5 ] Biotechnology products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.2.6 ] Human or animal extracted products
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
        [ 1.3.2.8 ] Other biological medicinal products
            Viral vectors
            Special Requirements
            Live Cells
             Advanced Therapy Medicinal Products
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.15 ] Other non-sterile medicinal products
            Cell based Advanced Therapeutic Medicinal Products
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological