It was confirmed that Eli Lilly and Company (Lilly), an American pharmaceutical company, warned Samsung Biologics about problems with its drug data management.
Previously, the U.S. FDA pointed out in its inspection report that "Samsung Bio failed to resolve data quality and integrity issues on time and did not notify client company of the problem in time." Accordingly, it seems inevitable that Samsung BioLogics' trust in manufacturing quality management will decline.
According to SBS BIZ in South Korea on the 6th, Lilly reportedly conducted an audit, pointing out that there were problems with Samsung Bio's drug data management.
Lilly audited the data management practices of Samsung Bio's research and development organization, 'MSAT (Manufacturing Science and Technology)', on July 6 and September 1 last year.
MSAT optimizes the customer's biopharmaceutical process technology for Samsung Biologics and continuously manages it to produce high-quality biopharmaceuticals.
Afterward, around September of last year, Samsung Bio's senior executives began a thorough investigation into data management, and as a result, the general manager resigned. It is reported that Samir Machhour, head of the Quality Operations Center, who led the comprehensive investigation at the time, recently left.
In addition, SBS BIZ announced on the 2nd of last month that Lilly issued a press release saying, "U.S. Food and Drug Administration Issues Complete Response Letter for Lebrikizumab Based on Inspection Findings at Third-Party Manufacturer." He said that rejecting new drug approval was a contract manufacturing issue, not a clinical one, and that the contract manufacturing company Lilly mentioned was Samsung Biologics.
An official from Samsung Biologics said in a phone call with Korea Duty-Free News on the 7th, "We have nothing to confirm or tell you about the customer," and "It is a bit difficult to provide an explanation (related to the issue)."
The link to the Korean version of this article is as below.
▷FDA 이어 美 제약회사 릴리도 삼성바이오로직스 데이터 관리 문제 지적
By_BK Min, KDFN kdf@kdfnews.com
