Shanghai Junshi Biosciences Co., Ltd. focuses on discovering and developing monoclonal antibody (MAb) drugs and also offers contract manufacturing. When it needed to establish a new biotech facility for commercial biomanufacturing, the company turned to NNE to provide the conceptual design, but the strong partnership extended into the following phases as well.
Shanghai Junshi Biosciences (Junshi) needed a large-scale commercial facility in Shanghai containing a large bulk and fill-finish process for the production of monoclonal antibodies (MAbs). Initially, the company looked for a project partner who could offer an engineering team consisting of US or European resources. Thus, Junshi planned to bring in NNE, which offered an entirely local team with support from our global biotech experts, Niels Guldager and Hartmut Schaz, as a sub-contractor.
Before making the final decision, however, Junshi sought the advice of another Chinese pharma manufacturer. NNE had delivered the biotech facility design for this company’s new MAb and aseptic filling facility and the customer had only positive things to say about the cooperation with NNE. Junshi thus decided to go for NNE as the sole service provider for the conceptual design.
Challenging solutions to achieve best-in-class facility design
Junshi’s project plan was to set up a common media and buffer area with four bulk lines. But after evaluating the project strategy and comparing solutions, the NNE team suggested to use modules instead. NNE recommended the use of modules because they are not only flexible, but are also very useful when critical processes need to be isolated, which fit well with Junshi’s needs as a contract manufacturing organization. By implementing a modular approach, Junshi would be able to scale the facility up or down by adding or removing modules from the process. In addition, modularity would save considerable investment in the initial stage of the project.
Junshi saw the benefits of this approach and chose to use four bulk modules with a separated media and buffer preparation area. “We were very happy that NNE were not afraid to challenge our initial solution," says COO at Junshi, Hui Feng and continues, "NNE’s strong technological competencies and expertise in pharmaceutical facility design ensured that we reached the best possible solution.”
We were very happy that NNE were not afraid to challenge our initial solution. NNE’s strong technological competencies and expertise in pharmaceutical facility design ensured that we reached the best possible solution.”
Because of NNE’s strong performance on the conceptual design, Junshi asked us to continue as its engineering partner for the basic design – something that is quite unusual in the Chinese market. “Such projects are often transferred to a local design institute after the conceptual design phase because of a limited budget on the customer side,” explains NNE’s Senior Process Specialist Kang Wei.
NNE then conducted the basic design in less than four months, finishing the project under budget and on schedule. Construction commenced shortly after the design handover, allowing the NNE team to see the fruits of their design quickly.
The facility is expected to become operational in October 2019, enabling Junshi to manufacture a varied portfolio of Mab products for international biotech customers.
Shanghai Junshi Biosciences Co. Ltd.
Dec. 2016 – Jul. 2017
Conceptual and basic design