Samsung BioLogics, a global leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) based in South Korea, announced today on October 1st, 2018 that its Plant 3, the world’s largest single bio manufacturing plant, has become cGMP ready and started production (OOF, out of freezing) after its successful validation.
Despite Plant 3 holds 20% larger capacity and 60% more facilities than Plant 2, Samsung BioLogics finished validation in just 10 months, 2 months faster than Plant 2 validation, utilizing know-hows accumulated from Plant 1 and 2.
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.
Samsung BioLogics optimized 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 minimize the validation period significantly.
In particular, about 1,200 samples are gathered daily during the validation stage. If one error occurs, more than a week required for rework and verification.
To minimize such errors, Samsung BioLogics has continuously conducted previous best-practice education, standardization 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%.
In addition, Samsung BioLogics standardized validation documents which enables greatly shortened the time required to create and review documents. Also it took a new approach that verify 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.
On the other hand, Samsung BioLogics has secured CDMO contracts with 24 companies for 33 products and received 19 global manufacturing approvals as of the end of September.