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Re: biosectinvestor post# 430128

Tuesday, 12/28/2021 2:17:13 PM

Tuesday, December 28, 2021 2:17:13 PM

Post# of 698803

and Advent is just the contract manufacturer and owns nothing




No? Advent does not own the certificate with the right to produce DCVAX L? Merck has little choice and must buy Advent if they want a CDMO with staff used to work with Flaskworks and owns the certificate to manufacture Biological investigational medicinal products.

Ofcourse Merck can find another contract manafacture but that will be way more expensive and takes way more time much easier to just buy Advent from Toucan. I bet that will happen

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

ADVENT BIOSERVICES LTD

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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