Samsung Biologics receives the 1st EMA Approval for its Plant No. 2 production 

?
- Licensed by EMA for its second plant only two months after FDA approval
- Successfully carried out FDA and EMA inspections simultaneously and
   received approvals from both global regulatory agencies. 

- Through continuous innovation, Samsung Biologics will supply stable production service for

   clients and patients in needs.

[Incheon, Korea] December 13th, 2017 ? Samsung Biologics announced today on December 13th, 2017 that it has been licensed by the Europe’s EMA (European Medicines Agency) for the first monoclonal antibody Drug Substance at its second plant, the world’s largest single plant with 150K liters capacity.

This approval is only two months after the FDA approval for the plant No. 2. Samsung Biologics carried out FDA and EMA inspections simultaneously. 

Plant No. 2 was constructed with Samsung Biologics’ unique design and construction method, which enables the company to install 10 bioreactors at a single plant. Plant No. 2 is five times larger and over 10 times more complicated than the industry average 30K capacity plant No. 1. Moreover the inspections were far more complicated because the FDA and EMA inspection period was overlapped. 

Samsung Biologics has set the record for the shortest time to get an approval in the industry with the plant No. 1 achieving FDA approval in 25 months after the plant started operation. The company broke its own world record with plant No.2 achieving the first approval in 19 months, 6 months faster than plant No. 1.

According to the "Report and Survey of Biopharmaceutical Manufacturing Capacity and Production" issued in 2017 by BioPlan Associate, a bio industry marketing research company, the most important factor for clients to choose CMOs is its ability to ‘stick to schedule’.

The reason ‘stick to schedule’ is important is that as the competition in the biopharmaceutical industry is becoming intense, it is important to advance into the market and preempt it. However there are more than 10 steps from CMO contract to tech transfer, inspection and production, which takes more than 4 years. Also the cost for clients during this period is about 20 million to 30 million dollars. Successful certification is the most important factor to stick to schedule as product release gets delayed if approval fails.

Samsung Biologics has significantly shortened the period of approval and allows the clients to quickly supply their products to the market in a timely manner.

?

Samsung Biologics has received 11 manufacturing approvals from US, Europe, and Japan, which are the top three global bio markets in merely six years since the establishment. The company has won 15 products manufacturing orders from 10 pharmaceutical companies including BMS and Roche.

On the other hand, plant No. 3, which was completed last month, has 180K capacity and Samsung Biologics is expected to become the world’s largest CMO with the total production capacity of 362K liters.

Tae Han Kim, CEO and President of Samsung Biologics, said “Samsung Biologics has proved once again that it possesses world class capability in quality as well as the production scales” and “We will continue to do our best to continuously innovate ourselves so that clients and patients can received medical products in a timely manner”.