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Quality mindset cultivated at Samsung Biologics
At Samsung Biologics, quality is a core value that all employees share and continuously pursue as a top priority. Having acquired partnerships with 17 of the world’s top 20 biopharmaceutical companies and emerging biotechs, the global CDMO has cultivated a quality mindset that permeates teams and processes.
“We have a unique perspective of observing industry trends thanks to a diverse client pool, which creates a store of experiences we can tap into,” said Alex Jung, Senior Director of Quality System & Compliance.
Beyond protocol to proactivity
“Partnering with experienced client companies some of whom have been around for half a century is like having a seasoned mentor whom we can partner with to align on proven best practices,” said Eunah Yoh, Director of Client Quality.
To integrate clients’ quality processes to scale-up and tech transfer, swiftly acting on feedback is key. With decades of best practices under their belt, quality teams understand the implicit purpose of each clients’ requests and apply corresponding aspects of quality to prioritize accordingly.
Proactively pursuing a quality mindset goes beyond complying with GMP regulations. Samsung Biologics is also investing in future-proof systems and processes: “Our AI quality platform has passed its infant stages and is consistently being improved,” said Hyunjin Choi, Director of Client Quality.
Created to facilitate text-based operations for employees, the generative AI infrastructure makes use of an internal database. For example, to respond to queries like how to generate standard operating procedures (SOPs) on aseptic techniques, the platform pulls up relevant SOP references with citations to document change control numbers and even incorporates a table format if needed. For maximum adoption, Samsung Biologics holds training sessions on its generative AI platform to all interested employees.
Creative ownership at work
AI tools in and of themselves cannot replace an organic mindset, or the physical space needed for biomanufacturing. A robust process to measure pH, for example, would have built-in systems to overcome uncertainties from readings that deviate from baselines.
High-quality medicines can only be produced in a manufacturing environment that eliminates any possibility for doubt.
“Given an end goal, the team gets to choose which path to take,” said Jung. “How you got the answer matters just as much as the answer itself.” A quality mindset at the collective level is formed by purposeful ownership of one’s work. As is with any problem-solving Yoh said: “Rather than telling clients that we will check on this or follow up on that, taking our responsibility seriously to actually bring a task to completion drives a client-first mindset from the bottom up.”
Details in data compliance
To Samsung Biologics’ data compliance expert, responsibility and pride in one’s work are the foundation for product quality and patient safety.
Form follows function in the molecular world; so does attention to detail in data compliance. What matters beyond technological solutions is who maintains a quality mindset in the long term to improve know-how. In addition to auditing vendors themselves, the expert’s team constantly polish the system to produce consistent results so that one plus one is always two.
Even how the number 7 is handwritten can be up for interpretation. Does the digit merit a slash in the middle? Can it take the extra vertical without being confused for a 9? “Sometimes it’s like walking on thin ice, but we have been robust to constructive feedback on our quality operations from multiple stakeholders for more than a decade,” said Jung.
One deviation in a project can translate to others, especially when a CDMO partner like Samsung Biologics handles processes for myriad products at a global scale. “Most of our quality documents are bilingual,” said Choi. “This is quite rare in the industry.” Along with the requisite qualifications for translation, those for aseptic technique take into account the reality that any level of contamination can be catastrophic. The process for selecting the right people for the right role becomes an art in itself.
An effective policy foundation
With the opening of Bio Campus II on the horizon, Samsung Biologics gears up for the strengthening of existing quality policies and systems that impact those on the ground in manufacturing roles. “We want to make sure our employees work in a conducive environment and to offer lasting fixes for problems,” said Choi.
Alongside efforts to align with expectations from clients who seek rapid regulatory approval, a clear direction for continuous improvement energizes the CDMO’s vision for being truly global by definition. Jung said: “We are building a quality system where no matter what geography or culture, clients can benefit from partnering with us.”
Related Contents
Life @ Samsung Biologics What defines a quality culture at Samsung Biologics?
Samsung BIO Insight Virtual technologies to enhance quality mindset and transform learning culture
Samsung BIO Insight Propelling Quality Through Innovation & Accumulated Expertise
At Samsung Biologics, quality is a core value that all employees share and continuously pursue as a top priority. Having acquired partnerships with 17 of the world’s top 20 biopharmaceutical companies and emerging biotechs, the global CDMO has cultivated a quality mindset that permeates teams and processes.
“We have a unique perspective of observing industry trends thanks to a diverse client pool, which creates a store of experiences we can tap into,” said Alex Jung, Senior Director of Quality System & Compliance.
Beyond protocol to proactivity
“Partnering with experienced client companies some of whom have been around for half a century is like having a seasoned mentor whom we can partner with to align on proven best practices,” said Eunah Yoh, Director of Client Quality.
To integrate clients’ quality processes to scale-up and tech transfer, swiftly acting on feedback is key. With decades of best practices under their belt, quality teams understand the implicit purpose of each clients’ requests and apply corresponding aspects of quality to prioritize accordingly.
Proactively pursuing a quality mindset goes beyond complying with GMP regulations. Samsung Biologics is also investing in future-proof systems and processes: “Our AI quality platform has passed its infant stages and is consistently being improved,” said Hyunjin Choi, Director of Client Quality.
Created to facilitate text-based operations for employees, the generative AI infrastructure makes use of an internal database. For example, to respond to queries like how to generate standard operating procedures (SOPs) on aseptic techniques, the platform pulls up relevant SOP references with citations to document change control numbers and even incorporates a table format if needed. For maximum adoption, Samsung Biologics holds training sessions on its generative AI platform to all interested employees.
Creative ownership at work
AI tools in and of themselves cannot replace an organic mindset, or the physical space needed for biomanufacturing. A robust process to measure pH, for example, would have built-in systems to overcome uncertainties from readings that deviate from baselines.
High-quality medicines can only be produced in a manufacturing environment that eliminates any possibility for doubt.
“Given an end goal, the team gets to choose which path to take,” said Jung. “How you got the answer matters just as much as the answer itself.” A quality mindset at the collective level is formed by purposeful ownership of one’s work. As is with any problem-solving Yoh said: “Rather than telling clients that we will check on this or follow up on that, taking our responsibility seriously to actually bring a task to completion drives a client-first mindset from the bottom up.”
Details in data compliance
To Samsung Biologics’ data compliance expert, responsibility and pride in one’s work are the foundation for product quality and patient safety.
Form follows function in the molecular world; so does attention to detail in data compliance. What matters beyond technological solutions is who maintains a quality mindset in the long term to improve know-how. In addition to auditing vendors themselves, the expert’s team constantly polish the system to produce consistent results so that one plus one is always two.
Even how the number 7 is handwritten can be up for interpretation. Does the digit merit a slash in the middle? Can it take the extra vertical without being confused for a 9? “Sometimes it’s like walking on thin ice, but we have been robust to constructive feedback on our quality operations from multiple stakeholders for more than a decade,” said Jung.
One deviation in a project can translate to others, especially when a CDMO partner like Samsung Biologics handles processes for myriad products at a global scale. “Most of our quality documents are bilingual,” said Choi. “This is quite rare in the industry.” Along with the requisite qualifications for translation, those for aseptic technique take into account the reality that any level of contamination can be catastrophic. The process for selecting the right people for the right role becomes an art in itself.
An effective policy foundation
With the opening of Bio Campus II on the horizon, Samsung Biologics gears up for the strengthening of existing quality policies and systems that impact those on the ground in manufacturing roles. “We want to make sure our employees work in a conducive environment and to offer lasting fixes for problems,” said Choi.
Alongside efforts to align with expectations from clients who seek rapid regulatory approval, a clear direction for continuous improvement energizes the CDMO’s vision for being truly global by definition. Jung said: “We are building a quality system where no matter what geography or culture, clients can benefit from partnering with us.”
Related Contents
Life @ Samsung Biologics What defines a quality culture at Samsung Biologics?
Samsung BIO Insight Virtual technologies to enhance quality mindset and transform learning culture
Samsung BIO Insight Propelling Quality Through Innovation & Accumulated Expertise