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 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 AUTOLUS LIMITED MODULE 3, MODULE 3, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, 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 | 18/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
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 |
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 |