Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 22774
2: Name of authorisation holder BIORELIANCE LIMITED
3: Address(es) of manufacturing site(s)

BIORELIANCE LIMITED, TODD CAMPUS, WEST OF SCOTLAND SCIENCE PARK, GLASGOW, G20 0XA, UNITED KINGDOM

4: Legally registered address of authorisation holder BIORELIANCE LIMITED, TODD CAMPUS, WEST OF SCOTLAND SCIENCE PARK, GLASGOW, G20 0XA, 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 15/09/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BIORELIANCE LIMITED, TODD CAMPUS, WEST OF SCOTLAND SCIENCE PARK, GLASGOW, G20 0XA, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.6 ] Other aseptically prepared products
            Preparation of low bioburden intermediate IMPs (under conditions equivalent to those required for as
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.4 ] Gene therapy products
        [ 1.3.1.5 ] Biotechnology products
        [ 1.3.1.6 ] Human or animal extracted 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
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological