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The Certificate has been invalidated, invalidated date is : 2024-07-11

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Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPE-CH-1005575

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Switzerland confirms the following:

The manufacturer: Lonza AG

Site address:	Lonzastrasse, Visp, 3930, Switzerland
Additional details on units inspected:	*This GMP-Certificate is valid for the site registered with Swissmedic: Lonza AG Biologics (NCA Reference Key 1107397)*

OMS Organisation Id. / OMS Location Id.: ORG-100011548 / LOC-100017781

Other

(Human) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

(Veterinary) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

(Investigational product) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-08-19 , it is considered that it complies with:

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

Part 2

Human Medicinal Products
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.6 Quality control testing

   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Manufacture of active substance. Names of substances subject to inspection:

[19]SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
Mammelian cells

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
Subunit or conjugate vaccines, manufactured biotechnologically

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

4. Other Activities - Active Substances:
Brentuximab vedotin, Brolucizumab, Certolizumab pegol, Enfortumab vedotin, L-asparaginase (GMP intermediate), Lonapegsomatropin, Mecasermin, Polatuzumab vedotin, Ranibizumab biosimilar, recombinant adenosine deaminase (GMP intermediate), Tisotumab vedotin, Trastuzumab deruxtecan, Trastuzumab emtansine

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