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06/07/2023 Quality, the Core Value of Samsung Bioepis
Established in 2012, Samsung Bioepis is a biopharmaceutical company dedicated to enhancing access to high-quality biologic medicines for patients. Through innovative research and development platforms, combined with optimized supply chain capability and extensive marketing partnerships, we have developed a broad and industry-leading portfolio of 10 biosimilars. Our biosimilars are positively impacting healthcare systems around the world by alleviating the burden of high healthcare costs while improving access to life-changing biologic treatments.

Samsung Bioepis Ensures Consistent Quality in Every Step of Development, Manufacturing, and Supply process.

Samsung Bioepis’ core values embody the central part of Samsung philosophy – devoting  one’s talent and technology to creating best-in-class products and services that contribute to a better global society – and that runs within the company. For biotech, this has been translated into a data-driven mindset that allows us to develop biologic medicines in the most efficient, yet rigorous way possible, so that quality is maintained at a consistent level from pre-clinical development to large-scale manufacturing. To date, the U.S. Food and Drug Administration (FDA) has not issued any warning letters to Samsung Bioepis regarding its manufacturing and development sites.1

Figure 1. Samsung Bioepis has not received any FDA warning letters for manufacturing and development sites.

a. Code name for Infliximab biosimilar (RENFLEXIS™), b. Code name for trastuzumab biosimilar (ONTRUZANT™), c. Code name for ranibizumab biosimilar (BYOOVIZ™), d. Code name for etanercept biosimilar (ETICOVO™), e. Code name for adalimumab biosimilar (HADLIMA™)

Bolstering Quality Assurance

All of our facilities spanning from development to manufacturing are subject to qualification and verification to assure their performance and functionality so that we can systematically manage variation, deviation, complaint and other issues. We also apply a quality assurance procedure to each step of our manufacturing process to deliver high-quality medicines.
In selecting new contract manufacturing organizations (CMOs), we assess their production capacity and risk management competency to ensure quality management and regulatory compliance, and continue with follow-up monitoring.
We also provide systematic internal/external quality training to help our employees bolster their quality improvement competency. Our new hires receive training on our quality management policy, and the departments that have direct impact on product quality receive annual GxP2) training to strengthen their quality assurance competency on an on-going basis. In doing so, we help our employees improve their awareness and competency on quality management. In addition, our partner suppliers have acquired GxP certification as a result of a total of 18 audits performed in the US, Europe and Korea since 2021, and we are regularly monitoring the due diligence findings and guidelines presented by the regulatory authorities.

What steps do we take to develop high-quality biosimilars that meet the rigorous regulatory standards?

· Characterization: Biosimilar development starts with a thorough understanding of the reference biologic. In order to thoroughly understand the reference product, we conduct rigorous and extensive analysis by sourcing over 100 lots of the reference product over 5 years (on average), and use more than 60 advanced methods for physicochemical and functional analysis.
· Cell Line Development: We screen over 15,000 single clones to discover the most optimal clone that will ultimately become the source of biosimilar production.
· Drug Substance Process Development: We conduct over 1,500 cell culture and purification experiments and gain over 15,000 analytical data to develop a process that maintains optimal producing conditions.
· Drug Product Process Development: We develop formulations that enable biosimilars to have stable finished dosage forms, for example, vial, syringe or autoinjector, for safe and convenient usage of medicines for patients.
· Scale-up: Our robust scale-up model ensures that quality is maintained from lab scale to commercial-production scale, based on extensive experimental data sets as well as computational simulation.
· Commercial manufacturing: We use strict quality control measures designed to ensure consistency, thereby minimizing batch-to-batch variations.

Figure 2. Samsung Bioepis has an advanced development platform which drives extensive analysis, risk management and rigorous quality control at each step of the development process, from pre-clinical to large scale manufacturing.

As a result, Samsung Bioepis has successfully delivered 51 million units of products in 40 countries (as of May 2023). Our biosimilars are helping to reduce the overall healthcare spending by providing comparable clinical benefits as reference products but at a lower cost. Biosimilars play a crucial role in maintaining healthcare systems’ sustainability as the savings from biosimilars can be utilized to improve the quality of patient care and other areas in public health. And as biosimilars create competition for biologic drugs that lose exclusivity, more innovation can happen in the field of next-generation treatments that address unmet medical needs. In doing so, we are driving progress towards a sustainable healthcare system.

1.Data on file, Samsung Bioepis Co., Ltd., as of Dec 2022
2.GxP is a series of quality guidelines and regulations created to ensure that biopharmaceutical products that are consumed, or used by humans or animals are safe, meet their intended use, and adhere to quality processes during manufacturing, quality control, storage and distribution. Examples include Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).

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