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Posted On: 07/27/2020 1:26:03 PM
Post# of 148917
Would SAMSUNG have to Increase Production Capacity for an approval
Samsung Biologics has been providing aseptic filling and lyophilization services since 2013 and has built a strong track record with 25 product approvals from global regulatory bodies, including the FDA and EMA.
In response to the forecasted increase in demand for aseptic filling, the company is making a strategic investment on its global capacity
by building a flexible filling line
and two additional lyophilizer units with 41.2 m2 chambers.
The flexible filling line is expected to commence GMP operations in the second half of 2021, and the expanded lyophilization line will become operational in the first half of 2022.
Through this expansion, Samsung Biologics will add small-scale cartridge and syringe filling to its DP product offerings, and increase the total lyophilization capacity by 246% of the current capacity. The company expects to demonstrate its ongoing commitment to reliability and quality-oriented services for its clients and strengthen existing partnerships in addition to procuring new orders.\
https://www.prnewswire.com/news-releases/sams...96607.html
Samsung Biologics has been providing aseptic filling and lyophilization services since 2013 and has built a strong track record with 25 product approvals from global regulatory bodies, including the FDA and EMA.
In response to the forecasted increase in demand for aseptic filling, the company is making a strategic investment on its global capacity
by building a flexible filling line
and two additional lyophilizer units with 41.2 m2 chambers.
The flexible filling line is expected to commence GMP operations in the second half of 2021, and the expanded lyophilization line will become operational in the first half of 2022.
Through this expansion, Samsung Biologics will add small-scale cartridge and syringe filling to its DP product offerings, and increase the total lyophilization capacity by 246% of the current capacity. The company expects to demonstrate its ongoing commitment to reliability and quality-oriented services for its clients and strengthen existing partnerships in addition to procuring new orders.\
https://www.prnewswire.com/news-releases/sams...96607.html
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