A biosafety toolbox for manufacturing with single-use systems

Abstract

As markets for recombinant biologicals constantly grow, risks related to the biohazardous materials used are not yet always understood and assessed systematically. Thus, there is a strong need to systematically assess technical solutions in GMP area and best practices for all steps in biotechnological production using biohazardous materials up to biological safety level 2. Especially Viral vectors, Virus based vaccines are more coming to market as novel therapies, asking for different safety requirements.

As Single Use Solutions (SUS) are widely used in clinical- and production scale in Upstream and Downstream processing until Final fill operations, new practices must be developed with a different approach enabling production under BSL2.

Production of biologics which are produced in BSL2 area regime using SU solutions must be reviewed under different aspects in terms of safety for the product + staff equally and probable contamination of the environment. SU Solutions for this new purpose must be differently handled with care from goods entry until final discard of products post usage. The production starting at fabricator of the SUS items itself might require modifications. The design of SUS items for the BSL2 purpose must be tested already in a different way in production, to fulfill the higher safety level regimes to protect the product and operators. In this paper we give examples for considerations how to unpack, store such SUS consumables and which conditions in the facility are favorable in combination with proper staff training Examples of suitable components and existing SUS equipment's for the Upstream- and Downstream processing of such products, to give operators, Suite- and plant managers, A+E with planers and people in regulatory departments the needed information, to enable the safe and regulatory aligned production of such biologic therapies.