Abstract
This publication describes the implementation and integration of a biosafety level 3 laboratory (BSL-3) unit within a drug discovery environment into a public multi-tenant and multi-user complex of buildings. The manuscript is intended to be used as guidance for any owners/users willing to build a laboratory unit of this type, including all steps from design to registration and certification.
The goal of integrating a BSL-3 laboratory, according to international standards, with a drug development unit and an animal facility for infection studies, in a mixed multi-user and multi-tenant building, under circumstances where biosafety legislation is still under development, can lead to a complex situation with conflicting demands and expectations of the involved parties and the public. To solve the potential conflicts, an innovative approach was chosen to optimize the design of the laboratory (basing the safety concept on user requirements and qualifications criteria, and developing technical solutions in compliance with a consensus of the most relevant international biosafety regulations).
We describe here the BSL-3 unit set-up, built for the Novartis Institute for Tropical Diseases (NITD), which moved in April 2004 to Biopolis in Singapore, where new laboratories compliant with international biosafety standards had to be set up. The project ran in six phases; after 14 months of construction and build-up, installation approval, commissioning and certification, the laboratory could be made available to users. After evaluation and approval of all Standard Operating Procedures (SOPs) with non-infectious agents, the laboratory could be used as a so-called “hot operation” with infectious agents.