CELL AND GENE THERAPY CATAPULT – MIA(IMP) 48152
| Authorisation Number | UK MIA(IMP) 48152 |
| Category | MIA(IMP) |
| Holder | CELL AND GENE THERAPY CATAPULT |
| Registered Address | CELL AND GENE THERAPY CATAPULT, 12TH FLOOR TOWER WING, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM |
| Authorisation Date | Feb 02, 2024 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 1 |
| Manufacturing Operations | 1.1 1.1.1 1.1.1.1 1.1.1.4 1.1.1.6 1.1.3 1.3 1.3.1 1.3.1.3 1.3.1.4 1.3.1.5 1.3.1.6 1.3.1.8 1.3.2 1.3.2.3 1.3.2.4 1.3.2.5 1.3.2.6 1.3.2.8 1.4 1.4.2 1.4.2.1 1.5 1.5.1 1.5.1.15 1.5.1.6 1.5.2 1.6 1.6.1 1.6.2 1.6.3 1.6.4 |
| MHRA Link | View on MHRA Website |
Sites (1)
CELL AND GENE THERAPY CATAPULT MANUFACTURING AND INNOVATION CENTRE
MANUFACTURING_SITE
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
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
1.1.1.4 — Small volume liquids
1.1.1.6 — Other aseptically prepared products
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
1.3.1.5 — Biotechnology products
1.3.1.6 — Human or animal extracted products
1.3.1.8 — Other biological medicinal products
1.3.2 — Batch certification
1.3.2.3 — Cell therapy products
1.3.2.4 — Gene therapy products
1.3.2.5 — Biotechnology products
1.3.2.6 — Human or animal extracted products
1.3.2.8 — Other biological medicinal products
1.4 — Other investigational medicinal products or manufacturing activitiy
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
1.5.1.15 — Other non-sterile medicinal products
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
1.6.4 — Biological
Content Preview
The source document is available on KeyPedia. Sign in to view.