Module 9 2021

19/03/2021

Why Virus Control is Important

The picture can't be displayed.

Implications of virus/bacteria Contamination to the Pharmaceutical Industry

1 Genentech Contamination with Mice Minute Virus (MVM) ● Facility cleandown and decontamination of whole plant ● Testing for MVM 2 Genzyme Contamination with Vesivirus ● Facility cleandown running to $10s of millions losses and interruption to the supply chain 3 Genentech contamination with Leptospira

● Agency Notification ● Root cause analysis ● Industry response

1 Garnick R.L. RawMaterials as a Source of Contamination Dev. Bio. Stand 1998 ; 93: 21-29

2 Genzyme Press Release: Genzyme Reports Progress Related to Allston Plant June 2009

3 Vinther Anders (2012) Novel Contamination Investigation in UpstreamDrug Substance Manufacturing Facility. PDA Annual Meeting in Phoenix Arizona 16th to 20th April 2012.

3

Virus RiskManagement for Biopharmaceutical Products

The picture can't be displayed.

Virus risk is addressed according to ICH Q5A ● Selecting and testing cell lines and other raw materials, including media components for the absence of undesirable viruses which may be infectious and/or pathogenic for humans  ● Assessing the capacity of the production processes to clear infectious viruses  ● Testing the product at appropriate steps of production for absence of contaminating infectious viruses  Facility and raw material risk assessment ● Vesivirus-Genzyme ● Upstream and downstream processing ● SARS-CoV-2 ADRM pose the highest risk

4

2