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The “Samsung Biologics Way” builds trust and ensures client satisfaction

4 Excellence Customer, Operation, Quality, People


Trust in partnerships between contract development and manufacturing organizations (CDMOs) and drug developers is essential. It enables CDMOs to adopt a client-centric mindset and allows drug developers to focus on bringing innovative drugs to patients without concerns about potential misalignment with their partners. 

 

Since its founding in 2011, Samsung Biologics has developed trust with its global partners through the “Samsung Biologics Way,” which is defined by four pillars of excellence. 

 

The Four Pillars of Excellence 

The pillars span four areas of excellence: customer, operational, quality, and people. Each pillar supports the others, creating a cohesive framework that ensures every aspect of CDMO operations is focused on achieving and maintaining client satisfaction and success.

 

Customer Excellence 

Transparency, which facilitates proactive knowledge sharing between CDMOs and their partners, is the backbone of client excellence. By centering daily operations and business development plans around client needs, CDMOs can effectively drive client success. 

 

Operational Excellence

An ongoing commitment to optimizing processes and standardizing systems for efficiency and data integrity is crucial for client satisfaction. Operational excellence enhances CDMOs’ ability to solve problems, safeguard the drug development life cycle, and ensure timely delivery of drugs to patients.

 

Quality Excellence 

A quality mindset and culture ensure that client programs stay compliant with evolving regulations. The best approach for CDMOs to maintain the necessary compliance is to integrate quality-by-design (QbD) principles from the start. By operating according to QbD principles, CDMOs can maintain robust data integrity, enable timely problem-solving when issues arise, and ultimately help clients overcome regulatory hurdles without delays.

 

People Excellence

A commitment to the continuous improvement of employee skills and abilities builds client trust that a CDMO is always ready to address their needs. With a focus on the future, CDMOs should invest in the ongoing development of their employees, ensuring they are prepared for today's challenges while also fostering tomorrow's innovations.

 

The four pillars are the very cornerstone of a trusted partnership. Values drug developers seek from their CDMO partners—such as transparency, accountability, and shared goals—come from CDMO operations driven by the four pillars. Such operations start with putting the client first and staying in step with what the partner needs now and will need down the road. Then, it's about getting the day-to-day right — smooth operations where clear communication and data handling mean fewer mix-ups and more forward momentum. Quality can't be an afterthought: It's always kept in focus, making sure every step moves things ahead to prepare for what regulators will demand. Of course, none of this works without the right people — who keep learning and growing and are ready to tackle any task. This solid base enables drug developers to stay focused on the big picture: researching, funding, and guiding their product through the regulatory process while holding firm trust that the CDMO is handling the rest of the development and manufacturing considerations.

 

Promises Delivered, Satisfaction Met 

Since its founding, Samsung Biologics has cultivated a tenure of trusted partnerships with over a hundred global drug developers, advancing their mission to bring innovative treatments to patients.

 

Samsung Biologics understands that drug developers navigate numerous clinical challenges and therefore require timely assistance from trusted partners to keep their development projects on track. 

This is why Samsung Biologics aligns its growth strategy, including capacity and portfolio expansion, with the goal of supporting its partners’ current and future projects. This ensures timely and reliable support whenever needed.

 

In 2021 Bolt Biotherapeutics, a California-based biotech, was looking for a reliable CDMO partner to develop a drug development solution. Committed to developing a myeloid-modulating agonist antibody that battles cancers, Bolt Biotherapeutics partnered with Samsung Biologics to earn investigational new drug (IND) approval for the agonist antibody within an expedited timeline. The Bolt and Samsung teams combined their expertise, driven by the belief that every second counts for patients waiting for a cure. Through swift and innovative actions, they developed an agile solution to keep the project on track for IND approval. This partnership extends beyond the initial goal—Samsung Biologics has committed to expanding its facilities, ensuring ongoing support for Bolt's pioneering drug as it progresses through successful clinical trials.

 

“Transparency in a partnership is extremely important because it allows us to have confidence in what we are receiving from our CDMO partner,” said a senior executive at Bolt. “Our earned confidence in Samsung Biologics’ end-to-end drug development service enabled us to take full advantage of its quality-centric, speedy execution and readily available bioreactors of various sizes to achieve our project goal. 

 

“The way Samsung is building new plants and adding capacity in the future gives us the confidence that a year or two from now, there will be adequate capacity, if our project is successful, for us to continue to work together.”

 

In 2022, another U.S. biotech, Aronora, sought cell line development support to advance its efforts in creating a lifeline for people battling blood clotting disorders. Aronora chose to partner with Samsung Biologics, known for its proven track record in developing high-quality cell lines and efficiently transitioning promising molecules from R&D to manufacturing.. Samsung Biologics’ blend of streamlined processes, end-to-end services, and dedication to excellence in their science, operations, and client project management allowed the CDMO to help Aronora develop a cell line with a titer nearly tenfold higher than that of its original cell line. 

 

The Samsung Biologics team “instantly understood our specific needs and were wholeheartedly collaborative throughout the entire process,” said a director of clinical operations at Aronora. “As a small company, we have really benefited and learned a lot about the entire process, rather than just looking at it piece by piece.”

 

The success of the cell line development project was driven by close-knit communication, which facilitated seamless collaboration between the teams at Aronora and Samsung Biologics. 

 

“The project managers at Samsung Biologics were very proactive with communication and responsive to our requests,” said the clinical operations director. “They always followed up to ensure that nothing fell through the cracks.

 

“We are truly in good hands with Samsung.”

 

Foundation of Trust in Partnerships

Trust lives at the core of daily operations at Samsung Biologics, embodying the promise the global CDMO brings to its partners. While business-to-business relationships are often considered transactional, Samsung Biologics believes its relationships with global drug developers go beyond mere transaction. This commitment to trust is what defines these relationships as true partnerships.

4 Excellence Customer, Operation, Quality, People

 

Trust in partnerships between contract development and manufacturing organizations (CDMOs) and drug developers is essential. It enables CDMOs to adopt a client-centric mindset and allows drug developers to focus on bringing innovative drugs to patients without concerns about potential misalignment with their partners. 

 

Since its founding in 2011, Samsung Biologics has developed trust with its global partners through the “Samsung Biologics Way,” which is defined by four pillars of excellence. 

 

The Four Pillars of Excellence 

The pillars span four areas of excellence: customer, operational, quality, and people. Each pillar supports the others, creating a cohesive framework that ensures every aspect of CDMO operations is focused on achieving and maintaining client satisfaction and success.

 

Customer Excellence 

Transparency, which facilitates proactive knowledge sharing between CDMOs and their partners, is the backbone of client excellence. By centering daily operations and business development plans around client needs, CDMOs can effectively drive client success. 

 

Operational Excellence

An ongoing commitment to optimizing processes and standardizing systems for efficiency and data integrity is crucial for client satisfaction. Operational excellence enhances CDMOs’ ability to solve problems, safeguard the drug development life cycle, and ensure timely delivery of drugs to patients.

 

Quality Excellence 

A quality mindset and culture ensure that client programs stay compliant with evolving regulations. The best approach for CDMOs to maintain the necessary compliance is to integrate quality-by-design (QbD) principles from the start. By operating according to QbD principles, CDMOs can maintain robust data integrity, enable timely problem-solving when issues arise, and ultimately help clients overcome regulatory hurdles without delays.

 

People Excellence

A commitment to the continuous improvement of employee skills and abilities builds client trust that a CDMO is always ready to address their needs. With a focus on the future, CDMOs should invest in the ongoing development of their employees, ensuring they are prepared for today's challenges while also fostering tomorrow's innovations.

 

The four pillars are the very cornerstone of a trusted partnership. Values drug developers seek from their CDMO partners—such as transparency, accountability, and shared goals—come from CDMO operations driven by the four pillars. Such operations start with putting the client first and staying in step with what the partner needs now and will need down the road. Then, it's about getting the day-to-day right — smooth operations where clear communication and data handling mean fewer mix-ups and more forward momentum. Quality can't be an afterthought: It's always kept in focus, making sure every step moves things ahead to prepare for what regulators will demand. Of course, none of this works without the right people — who keep learning and growing and are ready to tackle any task. This solid base enables drug developers to stay focused on the big picture: researching, funding, and guiding their product through the regulatory process while holding firm trust that the CDMO is handling the rest of the development and manufacturing considerations.

 

Promises Delivered, Satisfaction Met 

Since its founding, Samsung Biologics has cultivated a tenure of trusted partnerships with over a hundred global drug developers, advancing their mission to bring innovative treatments to patients.

 

Samsung Biologics understands that drug developers navigate numerous clinical challenges and therefore require timely assistance from trusted partners to keep their development projects on track. 

This is why Samsung Biologics aligns its growth strategy, including capacity and portfolio expansion, with the goal of supporting its partners’ current and future projects. This ensures timely and reliable support whenever needed.

 

In 2021 Bolt Biotherapeutics, a California-based biotech, was looking for a reliable CDMO partner to develop a drug development solution. Committed to developing a myeloid-modulating agonist antibody that battles cancers, Bolt Biotherapeutics partnered with Samsung Biologics to earn investigational new drug (IND) approval for the agonist antibody within an expedited timeline. The Bolt and Samsung teams combined their expertise, driven by the belief that every second counts for patients waiting for a cure. Through swift and innovative actions, they developed an agile solution to keep the project on track for IND approval. This partnership extends beyond the initial goal—Samsung Biologics has committed to expanding its facilities, ensuring ongoing support for Bolt's pioneering drug as it progresses through successful clinical trials.

 

“Transparency in a partnership is extremely important because it allows us to have confidence in what we are receiving from our CDMO partner,” said a senior executive at Bolt. “Our earned confidence in Samsung Biologics’ end-to-end drug development service enabled us to take full advantage of its quality-centric, speedy execution and readily available bioreactors of various sizes to achieve our project goal. 

 

“The way Samsung is building new plants and adding capacity in the future gives us the confidence that a year or two from now, there will be adequate capacity, if our project is successful, for us to continue to work together.”

 

In 2022, another U.S. biotech, Aronora, sought cell line development support to advance its efforts in creating a lifeline for people battling blood clotting disorders. Aronora chose to partner with Samsung Biologics, known for its proven track record in developing high-quality cell lines and efficiently transitioning promising molecules from R&D to manufacturing.. Samsung Biologics’ blend of streamlined processes, end-to-end services, and dedication to excellence in their science, operations, and client project management allowed the CDMO to help Aronora develop a cell line with a titer nearly tenfold higher than that of its original cell line. 

 

The Samsung Biologics team “instantly understood our specific needs and were wholeheartedly collaborative throughout the entire process,” said a director of clinical operations at Aronora. “As a small company, we have really benefited and learned a lot about the entire process, rather than just looking at it piece by piece.”

 

The success of the cell line development project was driven by close-knit communication, which facilitated seamless collaboration between the teams at Aronora and Samsung Biologics. 

 

“The project managers at Samsung Biologics were very proactive with communication and responsive to our requests,” said the clinical operations director. “They always followed up to ensure that nothing fell through the cracks.

 

“We are truly in good hands with Samsung.”

 

Foundation of Trust in Partnerships

Trust lives at the core of daily operations at Samsung Biologics, embodying the promise the global CDMO brings to its partners. While business-to-business relationships are often considered transactional, Samsung Biologics believes its relationships with global drug developers go beyond mere transaction. This commitment to trust is what defines these relationships as true partnerships.

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