Conceptual Design and Detailed Design Management for Nucleic Acid Drug Project

Project Introduction

The client required an integrated platform for nucleic acid drug research, clinical development, and commercial production within one leased building. The design scope includes process, architecture and MEP (mechanical, electrical, plumbing) engineering. The building comprises four floors with floor heights of 5m, 4.2m, 4.2m, and 4.2m, respectively. Each floor has an approximate area of 1500 square meters. The project design shall comply with the latest standards of NMPA, FDA and EU GMP.

The project requires partial renovation of the original structure, reconstruction of the roof structure, and reconstruction of the ground floor structure due to critical issues as insufficient load capacity, poor roof waterproofing, and cracks in the building floor.

Project Challenge

•Limited space 

•Numerous unfavorable conditions in the existing building pose challenges for energy efficiency and consumption reduction. 

•The building's load capacity was insufficient to meet production demands.

Scope of Services：CD、BD、DD

AUSTAR Contribution and Client Benefits

•Provide one technical solution that not only meets the production and research requirement, but also balances safety, compliance and convenience, as well as assisting in evaluating engineering solutions of other suppliers. 

•Achieved maximum capacity in limited space.

•Focused on GMP compliance (NMPA, EU, FDA cGMP) in process and facility design,  as well as other considerations of flexibility, scalability, Intellectual Property protection, and advanced technology application. 

•Achieved energy efficiency and value engineering.