Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 43821 |
|---|---|
| 2: Name of authorisation holder | ADAPTIMMUNE LIMITED |
| 3: Address(es) of manufacturing site(s) |
ADAPTIMMUNE LIMITED, 60 JUBILEE AVENUE, MILTON PARK, MILTON, ABINGDON, OX14 4RX, UNITED KINGDOM ADAPTIMMUNE LIMITED, MODULE 5, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ADAPTIMMUNE LIMITED, 60 JUBILEE AVENUE, MILTON PARK, MILTON, ABINGDON, OX14 4RX, 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 | 25/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ADAPTIMMUNE LIMITED, 60 JUBILEE AVENUE, MILTON PARK, MILTON, ABINGDON, OX14 4RX, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.3 ] Cell therapy products |
| [ 2.2.3.4 ] Gene therapy products |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ADAPTIMMUNE LIMITED, MODULE 5, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| 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 Ex vivo viral vector |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.4 ] Gene therapy products Special Requirements Ex vivo viral vectors |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |