Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 46113 |
|---|---|
| 2: Name of authorisation holder | AUTOLUS LIMITED |
| 3: Address(es) of manufacturing site(s) |
AUTOLUS LIMITED MODULE 3, MODULE 3, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM AUTOLUS LIMITED MODULE 4, MODULE 4, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM 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 | 15/05/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
AUTOLUS LIMITED MODULE 3, MODULE 3, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM
| 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 Vector |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
AUTOLUS LIMITED MODULE 4, MODULE 4, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, UNITED KINGDOM
| 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) |
| [ 1.1.1.1 ] 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 Therapies Special Requirements Live Cells |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational 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 |
AUTOLUS LIMITED THE NUCLEUS, THE NUCLEUS, MARSHGATE, STEVENAGE, SG1 1FR, UNITED KINGDOM
| 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) |
| [ 1.1.1.1 ] 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 therapies |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational 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 |