Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 45803 |
|---|---|
| 2: Name of authorisation holder | ROSLIN CELL THERAPIES LIMITED |
| 3: Address(es) of manufacturing site(s) |
ROSLINCT- BIOCUBE 2 , BIOCUBE 2, 11 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, UNITED KINGDOM ROSLINCT INSTITUTE FOR REGENERATION AND REPAIR NORTH, GMP CELLULAR THERAPY FACILITY, SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, EDINBURGH BIOQUARTER, 5 LITTLE FRANCE DRIVE, EDINBURGH, EH16 4UU, UNITED KINGDOM ROSLINCT - SHAWFAIR, 2 WESTER SHAWFAIR, DANDERHALL, DALKEITH, EH22 1FD, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ROSLIN CELL THERAPIES LIMITED, 9 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, 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 | 18/06/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
ROSLINCT- BIOCUBE 2 , BIOCUBE 2, 11 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, 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) |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.6 ] Other aseptically prepared products Cellular therapy products ( ATMPs), Master cell banks |
| [ 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 |
| [ 1.3.1.4 ] Gene therapy products Special Requirements Live Cells |
| [ 1.3.1.6 ] Human or animal extracted products Special Requirements Live Cells |
| [ 1.3.1.7 ] Tissue Engineered Products Special Requirements Live Cells |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.3 ] Cell therapy products Special Requirements Live Cells |
| [ 1.3.2.4 ] Gene therapy products Special Requirements Live Cells |
| [ 1.3.2.7 ] Tissue Engineered Products Special Requirements Live Cells |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.2 ] Secondary packaging |
ROSLINCT INSTITUTE FOR REGENERATION AND REPAIR NORTH, GMP CELLULAR THERAPY FACILITY, SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, EDINBURGH BIOQUARTER, 5 LITTLE FRANCE DRIVE, EDINBURGH, EH16 4UU, 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) |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.6 ] Other aseptically prepared products cellular therapy products (ATMPS), Master cell banks |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.3 ] Cell therapy products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.3.1.7 ] Tissue Engineered Products Special Requirements Live Cells |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.3 ] Cell therapy products |
| [ 1.3.2.4 ] Gene therapy products |
| [ 1.3.2.7 ] Tissue Engineered Products Special Requirements Live Cells |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.4 ] Biological |
ROSLINCT - SHAWFAIR, 2 WESTER SHAWFAIR, DANDERHALL, DALKEITH, EH22 1FD, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.3 ] Cell therapy products Special Requirements Live Cells |
| [ 1.3.2.4 ] Gene therapy products Special Requirements Live Cells |
| [ 1.3.2.6 ] Human or animal extracted products Special Requirements Live Cells |