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Wednesday, December 29, 2021 1:38:59 PM
The facility holds the licence.
HUH??? how can a property hold a license to produce Biological medicinal products? Impossoble. If ADVENT BIOSERVICES LTD would move out and a nearby Kabab Restaurant Ltd would move in would then have the Kabab Restaurant now have the right to produce live cells?
lykiri you are one of the finesest researchers here but comeon.
Read the license itself please:
Name of authorisation holder ADVENT BIOSERVICES LTD
HOLDER IS: ADVENT BIOSERVICES LTD not the property made out of bricks and cement
https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923
Medicines and Healthcare products Regulatory Agency
MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 54923
2: Name of authorisation holder ADVENT BIOSERVICES LTD
3: Address(es) of manufacturing site(s)
ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM
4: Legally registered address of authorisation holder ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031]
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 20/12/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM
Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological investigational medicinal products
[ 1.3.1 ] Biological medicinal products
[ 1.3.1.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.3.2 ] Batch certification
[ 1.3.2.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.5 ] Packaging
[ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
[ 1.6.4 ] Biological
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