GMP round-up: Samsung Bio becomes bigger, Rentschler fills aseptic gap

Korean CDMO Samsung BioLogics says its third facility is GMP ready and the largest single biomanufacturing plant in the world. Meanwhile, Rentschler has received GMP certification for an Austrian fill/finish plant.

Samsung BioLogics has begun production at its third plant at its site in Incheon, South Korea. With 180,000 L of capacity from 12 times 15,000 L tank, the plant is the world’s largest single facility, according to the contract development and manufacturing organization (CDMO).

It took Samsung BioLogics 10 months to obtain good manufacturing practice (GMP) for its third facility, the contract development and manufacturing organization (CDMO) said. This was two months faster than for the validation of its second plant.

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“Validation is practically the first step for manufacturing approvals and productions as the records filed during this stage are essential to receive global approvals in the future,” the firm said.

The opening of the plant almost doubles Samsung BioLogics’s current capacity. Its first plant has 30,000 L of capacity from six 5,000 L tanks and its second has 152,000 L at the Songdo site.

According to the firm, Samsung BioLogics has secured contracts with 24 companies for 33 products and received 19 global manufacturing approvals.

The plant’s opening is the latest development for the CDMO, which was only founded in 2011. The firm has also said it is looking at adding single-use capabilities, developing its own cell line service, and entering the cell therapy space.

Rentschler

Meanwhile in Rankweil, Austria, Rentschler Fill Solutions GmbH has received certification from AGES, the Austrian Agency for Health and Food Safety, and begun GMP operations.

The clinical and commercial site – which has capacity to handle batches of up to 60,000 vials and provides lyophilization capacity of 15m² – was announced in 2017 as part of Rentschler Biotechnologie’s strategic alliance with Leukocare.

The collaboration aims to offer formulation development, drug substance production and aseptic fill and finish, all from a single source.

“Our joint promise `one contact – one contract – one quality` represents our commitment to meet our clients’ product and safety requirements and to create the potential for expedited market entry,” Reinhold Elsaesser, executive manager at Rentschler Fill Solutions said.

“The combination of our reliable technology and customer oriented processes with the international experience of our experts, enables us to satisfy the high expectations of our customers and power their progress.”

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