Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 17479 |
|---|---|
| 2: Name of authorisation holder | OXFORD BIOMEDICA (UK) LIMITED |
| 3: Address(es) of manufacturing site(s) |
OXFORD BIOMEDICA (UK) LIMITED, UNIT A, PLOT 7000, ALEC ISSIGONIS WAY, OXFORD, OX4 2ZY, UNITED KINGDOM OXFORD BIOMEDICA (UK) LIMITED, UNIT 5, OXFORD PIONEER PARK, MEAD ROAD, YARNTON, KIDLINGTON, OXFORD, OX5 1QU, UNITED KINGDOM OXFORD BIOMEDICA (UK) LIMITED , COUNTY TRADING ESTATE, WATLINGTON ROAD, OXFORD, OX4 6LX, UNITED KINGDOM OXFORD BIOMEDICA (UK) LIMITED, WINDRUSH COURT, TRANSPORT WAY, OXFORD, OX4 6LT, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | OXFORD BIOMEDICA (UK) LIMITED, WINDRUSH COURT, WATLINGTON ROAD, OXFORD, OX4 6LT, 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 | 25/07/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
OXFORD BIOMEDICA (UK) LIMITED, UNIT A, PLOT 7000, ALEC ISSIGONIS WAY, OXFORD, OX4 2ZY, 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 |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.3 ] Cell therapy products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.3 ] Cell therapy products |
| [ 1.3.2.4 ] Gene therapy products |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Biological active starting materials |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
OXFORD BIOMEDICA (UK) LIMITED, UNIT 5, OXFORD PIONEER PARK, MEAD ROAD, YARNTON, KIDLINGTON, OXFORD, OX5 1QU, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.3 ] Cell therapy products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.3 ] Cell therapy products |
| [ 1.3.2.4 ] Gene therapy products |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Biological active starting materials |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
OXFORD BIOMEDICA (UK) LIMITED , COUNTY TRADING ESTATE, WATLINGTON ROAD, OXFORD, OX4 6LX, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.3 ] Cell therapy products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.3 ] Cell therapy products |
| [ 1.3.2.4 ] Gene therapy products |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Biological active starting materials |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
OXFORD BIOMEDICA (UK) LIMITED, WINDRUSH COURT, TRANSPORT WAY, OXFORD, OX4 6LT, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |