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 - SHAWFAIR, 2 WESTER SHAWFAIR, DANDERHALL, DALKEITH, EH22 1FD, 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- BIOCUBE 2 , BIOCUBE 2, 11 LITTLE FRANCE ROAD, EDINBURGH BIOQUARTER, EDINBURGH, EH16 4UX, 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 | 25/02/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
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 |
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- 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 |