Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 46113
2: Name of authorisation holder AUTOLUS LIMITED
3: Address(es) of manufacturing site(s)

AUTOLUS LIMITED THE NUCLEUS, THE NUCLEUS, MARSHGATE, STEVENAGE, SG1 1FR, UNITED KINGDOM

4: Legally registered address of authorisation holder AUTOLUS LIMITED, THE MEDIAWORKS, 191 WOOD LANE, LONDON, W12 7FP, 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 22/03/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AUTOLUS LIMITED THE NUCLEUS, THE NUCLEUS, MARSHGATE, STEVENAGE, SG1 1FR, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.1 ] Large volume liquids
            Special Requirements
            Live Cells
        [ 1.1.1.4 ] Small volume liquids
            Special Requirements
            Live Cells
        [ 1.1.1.6 ] Other aseptically prepared products
            Gene therapy
            Special Requirements
            Live Cells
    [ 1.1.3 ] Batch certification
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.4 ] Gene therapy products
            Special Requirements
            Live Cells
    [ 1.3.2 ] Batch certification
        [ 1.3.2.4 ] Gene therapy products
            Special Requirements
            Live Cells
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.4 ] Biological