State-of-the-Art Flexible Factory with Hybrid Commercial Manufacturing Process for Recombinant Proteins
With a facility design and construction satisfying global GMP standards, DMBio’s aim is to be one of the main players in the future global Biologics market.
DMBio, founded in 2013, is the result of a partnership between Dong-A Socio Holdings (Korea) and Meiji Seika Pharma (Japan).
With a facility design and construction satisfying global GMP standards, DMBio’s aim is to be one of the main players in the future global Biologics market.
DM bio’s competitiveness is strengthened by a process design allowing simultaneous production of multiple products. Moreover, their hybrid and flexible production system integrates the advantages of single-use and multi-use technologies to produce recombinant protein drugs efficiently, safely and cost effectively at various process scales.
"Sartorius Stedim Biotech impressed through their state-of-the-art single-use solutions and quality approach", said Dr. Kang CEO of Dong A Pharma. "The high level of expertise and very good communication between the partners resulted in excellent project execution. With our Hybrid Production Plant we are now able to meet cGMP commercial manufacturing requirements for our customers worldwide".
Sartorius delivered a full system integration including 3rd party equipment along the bioprocess through a redundant System Architecture, with Local Controller (HMI), Supervisory Control and Data Acquisition (SCADA) in a commercial manufacturing environment
In order to ensure the timeline targets Sartorius defined 3 subprojects in order to decouple the design phases of long lead equipment (multi-use) from short lead equipment (sinlge-use) and from Automation (SCADA Integration). The tough timeline targets required extensive project management skills and deeply geared schedules resulting in high collaboration within the core project team, and also with external partners and client’s contractors.
Due to a clear and lean execution model, the systems integration was done for the complete hybrid manufacturing process for all unit operations of Sartorius and third party vendors (GE, Westfalia, Bosch, Belimed). Thanks to redundancy for the automation architecture from the Upstream to Downstream, with single-use and multi-use process equipment, the facility is compliant with with the highest possible standards of process safety and traceability. With high expertise in single-use technologies, process design and engineering, Sartorius works with qualified single-use systems designs available from their standard library thus ensuring optimized supply chain management and cost efficiency.
