A Biosafety Toolbox for Manufacturing with Single-Use Systems.

Area of Science:

• Biotechnology and Biopharmaceutical Manufacturing
• Biosafety and Risk Assessment
• Good Manufacturing Practice (GMP)

Background:

• Growing recombinant biologicals market necessitates better risk assessment for biohazardous materials.
• Current practices may not adequately address safety for biological safety level 2 (BSL2) production, especially for viral vectors.
• Single-use solutions (SUSs) are prevalent but require adapted handling for BSL2 environments.

Purpose of the Study:

• To systematically assess technical solutions and best practices for biotechnological production using biohazardous materials up to BSL2.
• To develop new approaches for using SUSs in BSL2 production, ensuring product and staff safety.
• To provide information for safe and regulatory-aligned production of biologic therapies.

Main Methods:

• Review of current GMP and best practices for biohazardous material handling.
• Analysis of safety considerations for SUSs in BSL2 environments.
• Examples of unpacking, storage, facility conditions, and staff training for SUS consumables.

Main Results:

• Identified need for modified handling and design of SUS items for BSL2 production.
• Highlighted importance of facility conditions and staff training for safe SUS use.
• Provided examples of suitable SUS components and equipment for upstream and downstream processing.

Conclusions:

• Safe and regulatory-aligned production of biologic therapies requires a comprehensive approach to SUS management in BSL2.
• Modified SUS design, handling protocols, facility integration, and staff training are crucial for BSL2 environments.
• This work offers essential information for stakeholders involved in BSL2 biomanufacturing.