Facility in Incheon, South Korea, features 180,000L capacity, 20% more than its sister plant. The site passed validation in 10 months
Facility is designed to meet the requirements of US FDA, EMA, PMDA and other global regulatory agencies
Samsung BioLogics has announced that its Plant 3 has become cGMP ready and started production (OOF, out of freezing) after its successful validation.
Based in South Korea, Samsung BioLogics is a global biopharmaceutical contract development and manufacturing organisation (CDMO). Its manufacturing facilities are located near the Incheon International Airport in Incheon, and built on a single 68 acre site allowing for future expansion. Plant 3 is deemed the world’s largest single biomanufacturing plant.
Plant 3 holds 20% larger capacity and 60% more facilities than Plant 2, however, Samsung BioLogics finished validation in just 10 months; two months faster than Plant 2 validation. The company said utilising know-hows accumulated from Plant 1 and 2 made the process quicker.
Samsung BioLogics obtained about 4,500 verification records during the self-validation. 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 company said in a statement that it optimised and eliminated errors by applying accumulated construction and validation data and experiences from plant 1 and 2. As a result, the company was able to minimise the validation period significantly.
"In particular, about 1200 samples are gathered daily during the validation stage. If one error occurs, more than a week required for rework and verification," read the statement.
To minimise such errors, Samsung BioLogics has continuously conducted previous best-practice education, standardisation of sampling, and deployed experienced employees in the site where error occurs frequently. Because of these efforts, the company has reduced the error rate to as low as 0.02%.
Samsung BioLogics said it standardised validation documents, which greatly shortened the time required to create and review documents. In addition, it took a new approach that verifies one device as a representative of many that have the same mechanism. Consequently, it decreased by more than 17% from 8 to 6.6 verification documents per device, the company said.
Dr T.H Kim, president and CEO of Samsung BioLogics, said: “Plant 3 cGMP ready means that Samsung BioLogics has become the largest biomanufacturing CMO in the world." He added: “We will continue to go forth to change the paradigm of biopharmaceutical industry with its manufacturing competitiveness.”
Samsung BioLogics has also announced that it secured CDMO contracts with 24 companies for 33 products and received 19 global manufacturing approvals as of the end of September.