Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 59193 |
|---|---|
| 2: Name of authorisation holder | TOUCHLIGHT DNA SERVICES LIMITED |
| 3: Address(es) of manufacturing site(s) |
TOUCHLIGHT DNA SERVICES LIMITED (TDS), MORELANDS BUILDING, LOWER SUNBURY ROAD, HAMPTON, TW12 2ER, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | TOUCHLIGHT DNA SERVICES LIMITED, MORELANDS BUILDING, LOWER SUNBURY ROAD, HAMPTON, TW12 2ER, 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 | 23/01/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
TOUCHLIGHT DNA SERVICES LIMITED (TDS), MORELANDS BUILDING, LOWER SUNBURY ROAD, HAMPTON, TW12 2ER, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.15 ] Other non-sterile medicinal products Manufacture of low bioburden bulk active substance solutions in the form of small volume liquids for advanced therapy applications |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Synthetic DNA products: Enzymatic production of costumised DNA sequences in different DNA forms for use as active substances in vacines, therapuetics and/or starting materials for ATIMP applications. |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.8 ] Other biological medicinal products Synthetic DNA products: Enzymatic production of costumised DNA sequences in different DNA forms for use as active substances in vacines, therapuetics and/or starting materials for ATIMP applications. |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Synthetic DNA products - Enzymatic prodution of customised DNA sequences in different DNA forms for use as active substances in vaccines, therapeutics and/or as starting materials for ATIMP applications. |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.15 ] Other non-sterile medicinal products Primary packing of bulk small volume liquids |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |