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The Certificate has been withdrawn, withdrawn date is : 2025-02-18

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Landesamt Fuer Soziales Jugend Und Versorgung

CERTIFICATE NUMBER: DE_RP_01_GMP_2024_0005

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 15 of Directive 2001/20/EC as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: BioNTech Innovative Manufacturing Services GmbH

Site address:

Vollmersbachstrasse 52, Idar, Idar-Oberstein, Rhineland-Palatinate, 55743, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100032202 / LOC-100052030

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_RP_01_MIA_2024_0002 in accordance with Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import) and Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-06-15 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 15 of Directive 2001/20/EC and Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.1 Large volume liquids

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.4  Gene therapy products
   1.3.2  Batch Certification (list of product types)
           1.3.2.3  Cell therapy products
           1.3.2.4  Gene therapy products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: gamma irridiation of human cells to inhibit cell division APIs of genetically-engineered origin: - in vitro transcribed RNAs (PER-approach); - in vitro transcribed RNAs (RMAB-approach); subgroup of in vitro transcribed RNAs (PER-approach); - in vitro transcribed RNAs (unmodified RNAs,modified RNAs, self-amplifying RNAs) against infectious diseases (Lightspeed-Concept) - in vitro transcribed RNAs (Infectious Disease (RNA-ID)-Konzept (c1u RNAs and modified RNAs)(en)

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.3 Other importation activities

2.3.4 Other: Biological Active Substance - peripheral blood stem cells obtained by apheresis (autolog) for processing - human AB plasma for processing a clinical human investigational medicinal product(en)

Clarifying remarks (for public users):

Human Medicinal Products (attachment 1 part 1 of the manufacturer's authorisation): to 1.4.1.3 Manufacturing includes batch release. to 1.6: Quality control of RNA APIs for manufacturig of mRNA vaccines is also included. Investigational Medicinal Products (attachment 2 of the manufacturer's authorisation): to 1.1.1.1: L3P3 L3P3-Liposomes as IMP intermediate to 1.3.1.4 (Gene therapy products): - autologous CD8 positive T-cells, transduced with a modified T-cell receptor; -autologous T-cells, transduced with a chimeric antigen receptor (CG001.2 CAR-T). - automated manufacturing of autologous CLDN6 CAR-T cells (CG001.2 CAR-T) Apheresis and collection of whole blood and bone marrow are not carried out by BioNTech Innovative Manufacturing Services GmbH. in vitro transcribed RNAs: - not patient-customized in vitro transcribed RNAs (Warehouse-concept); - in vitro transcribed RNAs for immunotherapy against cancer (RCM-concept and RCM-LPX-process); - in vitro trans (text missing)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_RP_01_GMP_2025_0005

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_RP_01_GMP_2025_0005

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For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.