Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 47800
2: Name of authorisation holder BIOTHERAPY SERVICES LIMITED
3: Address(es) of manufacturing site(s)

BRADFORD ROYAL INFIRMARY, DUCKWORTH LANE, BRADFORD, BD9 6RJ, UNITED KINGDOM

ROYAL LONDON HOSPITAL, WHITECHAPEL, LONDON, E1 1BB, UNITED KINGDOM

ROYAL FREE HOSPITAL, ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, UNITED KINGDOM

LOUGHBOROUGH HOSPITAL, HOSPITAL WAY, LOUGHBOROUGH, LE11 5JY, UNITED KINGDOM

4: Legally registered address of authorisation holder BIOTHERAPY SERVICES LIMITED, CLARENCE CENTRE FOR ENTERPRISE & INNOVATION, 6 ST. GEORGES CIRCUS, LONDON, SE1 6FE, 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 21/06/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BRADFORD ROYAL INFIRMARY, DUCKWORTH LANE, BRADFORD, BD9 6RJ, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.15 ] Other non-sterile medicinal products
            RAPID Biodynamic Platelet Rich Plasma (RAPID PRP Gel) Haematogel wound dressing
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.1 ] Blood products
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.8 ] Other biological medicinal products
            RAPID PRP Gel
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.6 ] Human or animal extracted products
        [ 1.3.2.8 ] Other biological medicinal products
            RAPID PRP Gel
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROYAL LONDON HOSPITAL, WHITECHAPEL, LONDON, E1 1BB, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.15 ] Other non-sterile medicinal products
            976000101/ABS-10066 Angel Concentrated Platelet Rich Plasma Whole Blood Processing System, is a table-top, blood processing machine for the point-of-care production of the concentrated platelet rich plasma
            Special Requirements
            Point-of-care processing and delivery of the autologous RAPID PRP Gel.
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.1 ] Blood products
            Special Requirements
            Point-of-care processing and delivery of the autologous RAPID PRP Gel.
        [ 1.3.1.6 ] Human or animal extracted products
            Special Requirements
            The processed autologous RAPID Biodynamic PRP Haematogel contains concentrated PRP, which is converted to a gel, using autologous thrombin and ascorbic acid, produced at point-of-care
        [ 1.3.1.8 ] Other biological medicinal products
            The autologous RAPID Biodynamic PRP Haematogel biologically active dressing that will be produced at point-of-care.
            Special Requirements
            Point-of-care processing and delivery of the autologous RAPID PRP Gel.
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
Special Requirements
            Point-of-care processing and delivery of the autologous RAPID PRP Gel.
        [ 1.3.2.6 ] Human or animal extracted products
            Special Requirements
            The processed autologous RAPID Biodynamic PRP Haematogel contains concentrated PRP, which is converted to a gel, using autologous thrombin and ascorbic acid, produced at point-of-care
        [ 1.3.2.8 ] Other biological medicinal products
            The autologous RAPID Biodynamic PRP Haematogel biologically active dressing that will be produced at point-of-care.
            Special Requirements
            Point-of-care processing and delivery of the autologous RAPID PRP Gel.
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROYAL FREE HOSPITAL, ROYAL FREE HOSPITAL, POND STREET, LONDON, NW3 2QG, 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
        [ 1.3.1.8 ] Other biological medicinal products
            Radip PRP Gel
    [ 1.3.2 ] Batch certification
        [ 1.3.2.8 ] Other biological medicinal products
            Radip PRP Gel
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

LOUGHBOROUGH HOSPITAL, HOSPITAL WAY, LOUGHBOROUGH, LE11 5JY, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.15 ] Other non-sterile medicinal products
            RAPID Biodynamic Platelet Rich Plasma (RAPID PRP Gel) Haematogel wound dressing
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.1 ] Blood products
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.8 ] Other biological medicinal products
            RAPID PRP Gel
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.6 ] Human or animal extracted products
        [ 1.3.2.8 ] Other biological medicinal products
            RAPID PRP Gel