Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 58032
2: Name of authorisation holder RENTSCHLER ATMP LIMITED
3: Address(es) of manufacturing site(s)

RENTSCHLER ATMP LIMITED, MODULE 12, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM

RENTSCHLER ATMP LIMITED, SYCAMORE HOUSE, LEYDEN ROAD, STEVENAGE, SG1 2BP, UNITED KINGDOM

4: Legally registered address of authorisation holder RENTSCHLER ATMP LIMITED, 4 FLEET PLACE, LONDON, EC4M 7RD, 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 14/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

RENTSCHLER ATMP LIMITED, MODULE 12, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.5 ] Biotechnology products
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.3 ] Other
            Environmental monitoring or process simulation (media fill) to support sterile manufacture
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

RENTSCHLER ATMP LIMITED, SYCAMORE HOUSE, LEYDEN ROAD, STEVENAGE, SG1 2BP, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological