[비즈한국] Samsung Biologics has newly recruited an international expert with over 20 years of experience in quality management at global pharmaceutical and biopharmaceutical companies, as well as in CDMO (Contract Development and Manufacturing Organization) operations. This move is particularly notable as it comes during a period of rapid international expansion for the company, following the enlargement of its domestic production facilities, the acquisition of a production base in the U.S., and its pursuit of acquiring the global peptide CDMO PolyPeptide Group.
According to the Financial Supervisory Service's Data Analysis, Retrieval and Transfer System (DART) on the 14th, Samsung Biologics hired Carolina Valoyes as Vice President of QA (Quality Assurance) last July. Valoyes, a U.S. citizen, previously served as an executive in charge of quality for the CGT (Cell and Gene Therapy) division of the global CDMO Catalent, and also held quality-related executive roles at Bionova Scientific and Boehringer Ingelheim.
Vice President Valoyes possesses expertise spanning manufacturing sites, quality assurance, global Quality Management Systems (QMS), and compliance. Having worked in manufacturing and quality-related roles at global pharmaceutical and biotech firms such as Bayer, Amgen, Novartis, and Gilead, she subsequently managed global quality systems at Boehringer Ingelheim. Specifically, at Boehringer Ingelheim, she was responsible for establishing quality management system strategies and implementing them across the organization.
This marks the first time in approximately two and a half years that Samsung Biologics has recruited an overseas global QA expert as an executive, following the departure of former Vice President Keith Ellis, whose contract ended on January 31, 2024.
Industry observers believe that the recruitment of Valoyes will provide further momentum to Samsung Biologics' strategy of standardizing its quality systems as it rapidly expands its global production network.
Following the full-scale operation of its 180,000-liter Plant 5 last April, Samsung Biologics secured a biopharmaceutical production facility in Rockville, Maryland, USA, earlier this year. This marks the first time the company's production network, previously centered in Songdo, has expanded into the United States.
Furthermore, the company is pursuing the acquisition of the global peptide CDMO PolyPeptide Group with an investment of approximately 1.46 billion Swiss francs (2.7 trillion won).
Once the acquisition of PolyPeptide is complete, Samsung Biologics’ global production network will extend to Sweden, Belgium, and France, as well as Torrance and San Diego in the U.S., and India. The plan is to expand the business portfolio to include peptides, alongside existing antibodies, ADCs (Antibody-Drug Conjugates), and mRNA (messenger ribonucleic acid), while simultaneously enlarging the global production network.
As the number of production bases increases, the ability to minimize quality variations between plants and operate diverse facilities under a unified quality standard becomes increasingly critical.
Following the completion of Plant 5, Samsung Biologics formalized its proprietary standard production system, "ExellenS." The strategy is to standardize the design, equipment, processes, and operational methods of production facilities to ensure site-to-site equivalence, delivering the same level of process performance and quality at any production base. Once facilities are standardized, the company can reduce the burden of process changes when transferring client products from one plant to another and accelerate the speed of technology transfers.