Samsung BioLogics announced 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.
 
Dr. T.H Kim, the president and chief executive officer of Samsung BioLogics, said “Plant 3 cGMP ready means that Samsung BioLogics has become the largest bio manufacturing CMO in the world. We will continue to go forth to change the paradigm of biopharmaceutical industry with its manufacturing competitiveness”