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26/10/2022 Inside the Lab: A Decade of Innovating Access
From 2012, Samsung Bioepis has been committed to unlocking the healthcare of the future. When it comes to healthcare innovation, R&D expertise is key to our continued success—our dynamic and diverse workforce has worked relentlessly toward taking medicine to new heights.  
In light of our 10th anniversary, our scientists share what makes our research capabilities special, and why working at Samsung Bioepis sparks their passion for health.  
Cell Line Development Group: Where Biosimilars Begin
Selecting the cell line is a critical part of biosimilar development as it can determine the characteristics of the biosimilar product. Hence, our scientists strive to determine whether the completed cell strain will be suitable for biosimilar development.  
Juhyun Hong, a scientist within the Cell Line Development Group, emphasizes the significance of the team’s role in the overall biosimilar development. Cell line development is followed by developing and managing the Working Cell Bank (WCB).  

“The Cell Line Development Group completes the first step of biosimilar development,” says Juhyun.
When working on process innovation, Juhyun takes pride in building foundations for the potential cell lines, which are to be processed during cell line development process as host cell lines. Due to the delicate nature of the work, a data-driven mindset as well as in-depth cell engineering knowledge is necessary.  
Manufacturing Science Group: Ensuring Biosimilar Development Process  
Joonwoo Hwang, a scientist of the Manufacturing Science Group, works on process characterization studies (PC studies) for drug purification. This process ensures that the process involved in biosimilar development is as robust as it should be.  
In the context of biosimilar R&D, this scientific process is considered robust when the results of the experiment are consistent throughout changes in temperature and fluid flow conditions, for example. PC study is instrumental in thoroughly understanding a variety of risk factors that can affect the pharmaceutical manufacturing process. During this process, the team establishes an appropriate risk mitigation strategy, a mandatory step prior to Good Manufacturing Practice (GMP) production.  

“Process Characterization study is about thoroughly understanding a variety of factors within the experiment from a wide perspective,” says Joonwoo.
Joonwoo also compares medicine production to winemaking—just as a variety of factors come into play when producing wine, a multitude of factors, such as temperature, pH and flow rate, are to be considered in order to achieve the optimal results during the purification process.  
Quality Assurance: In Keeping with Biosimilars’ Purpose  
The Quality Assurance Group’s main task is to assure that the quality of medicine stays in compliance with the objectives. Quality assurance is part of each stage within the drug’s life cycle: production, release and marketing, and administration by patients.    
Hyeonsoo Lee, a scientist of the Quality Assurance Group, is responsible for ensuring the target quality throughout the drug life cycle, from development to commercial production, shipment, and to the moment the patient uses the product. She manages and assesses every process that may affect drug quality based on scientific evidence to make everything GMP-compliant.

“The great advantage of working as a QA professional in Samsung Bioepis is that you can build your experience in many ways and broaden your scope of work, with having opportunities to truly become professional beyond your expectations,” says Hyeonsoo.

Despite the data-driven nature of the work, Hyeonsoo identifies communication skills and persuasiveness as some of the most valuable skills for the task. Actively listening to our various stakeholders is also important when it comes to quality assurance. 
Pharmacovigilance: Safety First  
Paola Russo is a director within the Pharmacovigilance Group at Samsung Bioepis. While overseeing the development from start to finish, she ensures that drug safety considerations are kept at all stages of the lifecycle of the drug.  

“Drug safety is all about risk assessment and management...Samsung Bioepis has all the capabilities and potential to make biosimilars in smarter and faster ways,” says Paola.

Risk management is a key component to pharmacovigilance, says Paola. Collecting and analyzing data with anticipation of risks in mind—is an important aspect of her work. Samsung Bioepis’ strength lies in an efficient business model based on its other core assets. The trustworthy system allows its scientists to establish and maintain alliances as well as local partnerships, ultimately streamlining key processes.  
For Paola, advancing her career at Samsung Bioepis means gaining deeper insight and perspective of the full lifecycle of medicine. A medical doctor herself, she envisions a future with a limitless array of directions, as well as opportunities to work with others.  
Looking Ahead to the Future of Healthcare 
Samsung Bioepis’ dedication to expanding access to biologic medicines for patients all over the world have driven us toward important milestones throughout our journey.  
Going forward, we aim to maintain our unparalleled approach to biosimilar development and innovating access to healthcare. We are excited to see what the next 10 years will bring as we continue to enhance the lives of patients through our pioneering use of science and technology.

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