Virus and Endotoxin Clearance Strategies for Safe and Reliable Production of AAV

The project aims to develop a scalable viral and endotoxin clearance platform in an AAV manufacturing process via orthogonal methods. This will enable a platform process that will be available to the gene therapy industry.

Project status

100% Completed

Industry Need

Viral and endotoxin clearance strategies have been widely used in the monoclonal antibody (mAb) industry to remove viruses derived from mammalian cell lines and to remove possible adventitious viruses and endotoxins introduced during production.
Viral and endotoxin clearance is a relatively new topic in the field of gene therapy, especially in the production of adeno-associated viruses (AAV). However, some of the traditional viral clearance methods used in the mAb industry do not work as well, due to the inherent challenges of trying to remove viruses, while trying to retain the virus of interest (AAV).
Regulatory agencies do not explicitly state that viral clearance is needed for cell and gene therapy products, but ICH Q5A states that any product that is derived from a human, mammalian or insect cell line must have a drug product that is free from viruses.

Solution

Cytiva and BioCentriq aim to develop an orthogonal, scalable approach for viral clearance in an AAV manufacturing process to deliver a virus- and endotoxin-free therapy for patients.

Impacts

A reliable approach for viral clearance in AAV manufacturing that can help ensure virus- and endotoxin-free therapy for patients.

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Project Lead

BioCentriq, Inc.

Participating Organizations

Cytiva