Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 54923
2: Name of authorisation holder ADVENT BIOSERVICES LTD
3: Address(es) of manufacturing site(s)

ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM

4: Legally registered address of authorisation holder ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, 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 20/12/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.6 ] Other aseptically prepared products
            Cellular therapy 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
    [ 1.3.2 ] Batch certification
        [ 1.3.2.3 ] Cell 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
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.6 ] Other aseptically prepared products
            Cellular therapy 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
    [ 1.3.2 ] Batch certification
        [ 1.3.2.3 ] Cell 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
[ 2.3 ] Other Importation Activities
    [ 2.3.4 ] Other
        Importation of QP-certified IMPs from a country on the approved country for import list'