About This Project

Samsung Biologics will build a new five storey MMP facility in South Korea for the manufacturing of plasmid DNA, viral vectors for cell and gene therapy applications and microbial based MAbs. The facility will also include associated support functions such as QC and Process Development Laboratories.

Project Scope

DPS is completing a concept study determining key aspects of multimodal facilities such as flexibility, rapid deployment of new products, modularity, maximum use of single use systems, biocontainment, biosafety and HVAC strategies. DPS’s scope includes the design of a Process Development Laboratory.
The new multi-modality facility will comprise multiple drug substance development and cGMP production areas for viral vector manufacturing, microbial based plasmid DNA (pDNA) and monoclonal antibodies (MAbs), and a drug product final fill and finish suite. DPS’s scope comprises process design, including capacity modelling, utilities strategies, process architecture, process automation, and HVAC concepts including HVAC strategy for BLS2 and 2+ bio-safety requirements. Scope includes assessment of global regulatory requirements for multiple regulatory agencies.

Process

The facility will accommodate various operational scenarios due the nature of the CDMO business model. The viral vector suites considers flexible production scales (100L to 2,000L). The process design includes multiple viral vector manufacturing (trains) to accommodate various products in each (Lentivirus Vector  (LV), Adeno Associated Viral Vector (AAV), Adenovirus Vector (AdV) and Oncolytic Virus (OV)) as well as microbial fermentation suites for Plasmid DNA, and microbial based MAbs at a range of scales, 50L to 300L. The process team conducted an assessment of the facility throughout and capacity model to ensure the best fit facility for multiple product handling, ensuring appropriate personnel and product safety and cross contamination control strategies.