AUTOLUS LIMITED – MIA(IMP) 46113
| Authorisation Number | UK MIA(IMP) 46113 |
| Category | MIA(IMP) |
| Holder | AUTOLUS LIMITED |
| Registered Address | AUTOLUS LIMITED, 5TH FLOOR THE MEDIAWORKS, 191 WOOD LANE, LONDON, W12 7FP, UNITED KINGDOM |
| Authorisation Date | Jan 27, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 2 |
| 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 1.3.1.4 1.3.2 1.3.2.4 1.5 1.5.2 1.6 1.6.1 1.6.2 1.6.4 |
| MHRA Link | View on MHRA Website |
Sites (2)
AUTOLUS LIMITED MODULE 4
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
1.3.1.4 — Gene therapy products
1.3.2 — Batch certification
1.3.2.4 — Gene therapy products
1.5 — Packaging
1.5.2 — Secondary packaging
AUTOLUS LIMITED THE NUCLEUS
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
1.3.1.4 — Gene therapy products
1.3.2 — Batch certification
1.3.2.4 — Gene therapy products
1.5 — Packaging
1.5.2 — Secondary packaging
1.6 — Quality control testing
1.6.1 — Microbiological: sterility
1.6.2 — Microbiological: non-sterility
1.6.4 — Biological
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