Songdo Plant #2
Plant #2 marks the company’s step towards becoming a prominent CMO contractor both in scale and quality. Our quick delivery schedule is unparalleled in the history of the Biopharma industry. The facility design offers full compliance with global standards and world quality systems. Operational excellence is simultaneously achieved while offering a flexible engagement model to customers. Plant #2 is the pinnacle of Samsung’s forty years of engineering and construction expertise, fully integrated with a dedicated workforce with uncompromising attitudes towards achieving excellence and overcoming ever-difficult challenges.
Key Specifications items include Ground Breaking, Mechanical Completion, Facility Qualification, cGMP Ready, Production Capacity, Culture Type, Fill & Finish, Laboratories, Warehouse, and so on.
||February 2015 (17 Months)
||152,000 L (10X15KL)
|Fill & Finish
- QC lab expansion in Plant 1
- PD lab expansion in Plant 2
|Clinical Manufacturing Plant
- 2 of 1KL Bioreactor with single use
- Clinical Stage
- Process Development
- *In addition to 150KL manufacturing capacity
- Dedicated weigh and dispensing Freezer room(-20~40°C)
"We never lost our confidence despite the various challenges during this long-term project. We analyzed risk factors, made improvements, and then iteratively reviewed and managed the plan in ever increasing detail. We closed ranks to complete our mission and finally finished on time."
Plant #2 Project Team
QThe 2nd plant is bigger in size, and successfully manages to have great facilities and air quality. This seems like something that would be quite difficult to do. What was the know-how you needed to achieve such success?
AnswerSince Plant #2 was built based on the first one, we needed to make improvement in all aspects. Fortunately, our employees and partners had already gained much experience. Nevertheless, the construction effort was quite daunting. The second factory was 5 times bigger in production scale, and 1.5 times bigger in size than the first factory. By analyzing past mistakes as well as the parts that were yet to be completed, we were able to complete the construction to our satisfaction.
QThe plant was finished in a short amount of time. What made this possible?
AnswerThe key was teamwork. And it took a lot of understanding and sacrifice. In order to set common goals, more than a hundred of us gathered every Monday morning to share current status and issues. In addition, daily meetings were held, and cooperation between all divisions including Engineering, Operations, QA, QC, Validation, and other supporting teams made success possible.
QPlant foundation, facilities operation, maintenance and production were all planned for with successful performance in mind. What are the key features unique to Plant #2?
AnswerSince the second plant was based on the first, our systems must be improved. One of the unique features of Plant #2 is the significantly higher productivity and efficiency compared to Plant #1. By challenging the standard concept of setting 6 culture mediums and 1 refining line, we re-engineered our design for 10 culture mediums and 1 refining line.
QWhat difficulties did you have? Is there anything you want to tell your team members?
AnswerWe actually felt great pressure since the first plant was successfully launched. There were several issues to be fixed, and it could delay the whole project. We never lost our confidence despite the various challenges during this long-term project. We analyzed risk factors, made improvements, and then iteratively reviewed and managed the plan in ever increasing detail. We closed ranks to complete our mission and finally finished on time. I am humbled by and really appreciate everyone’s effort and sacrifice.