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Forging a trusted partnership in end-to-end drug development
How Samsung Biologics fostered a collaborative and transparent environment
to meet a client’s time-sensitive project deadline
Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics
A fundamental consideration when a biotech company seeks to outsource its project from cell line development to Investigational New Drug (IND) submission is the selection of a CDMO partner who can offer transparency and find innovative solutions.
Open communication between a biotech and CDMO forges a trusted partnership, enables close collaboration, and facilitates timely problem-solving, ultimately leading to end-goal success. This was the case for Bolt Biotherapeutics Inc., which needed a competitive CDMO partner to help advance its molecules to IND filing within a condensed timeline.
“Transparency in a partnership is extremely important because it allows us to have confidence in what we are receiving from our CDMO partner,” said Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics. “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.”
Creating the best solution through transparent collaboration
Bolt is a clinical-stage biotechnology company committed to developing new medicines to address key unmet medical needs for cancer patients. The California-based biotech company is developing a myeloid modulating agonist antibody (BDC-3042) that could potentially convert tumor-supportive white blood cells, or macrophages, into ones that kill tumors.
Bolt hopes to gain authorization to begin testing its antibody in clinical trials as soon as possible and has partnered with Samsung Biologics to accelerate the execution of its early-phase drug development for IND submission.
To deliver on its client’s needs, Samsung Biologics proposed a 12-month timeline from cell line development to IND filing.
“Any CDMO could propose a very fast timeline,” Ihle said. “But if it wasn’t logical, we wouldn’t trust the CDMO. What Samsung proposed was fast but believable.”
While executing the project, however, there was a hurdle that could delay the timeline. During the process development phase, an unexpected impurity was detected, and an additional purification column was needed to ensure the quality of the vials. Samsung Biologics and Bolt confronted the problem immediately, transparently shared each other’s concerns, and “talked through those in a collaborative problem-solving way,” Ihle said.
In a collective effort to bring creative solutions to the problem, Samsung Biologics shared its years of cumulative project know-how with processing purification using multiple columns, while Bolt shared its scientific and experimental knowledge. Both teams eventually managed to implement the extra-column purification process without delaying the project.
“This is why transparency is so important to me,” Ihle said. “It helps lead to successful execution and creating not just good enough solutions but the best solutions.”
Emboldening hope for successful drug development, envisioning future partnership
Successful teamwork driven by the transparent sharing of information between Samsung Biologics and Bolt ultimately led BDC-3042 to be filed for IND application on schedule with the United States Food and Drug Administration (US FDA).
When asked to describe the moment he first learned of the successful completion of the drug-development project, Ihle summed it up in one word.
“It’s hopefulness,” he said. “We invested so much effort and passion into the project. And getting to the point of actually having the high-quality drug in a vial ready to administer to patients brings us hope that one day, our drugs that Samsung is manufacturing for us will save lives.”
For a CDMO to carry out an accelerated end-to-end drug development project, it requires technical expertise and experience as well as the capacity that enables the CDMO to readily provide services to its clients when they need them.
“The amount of attention to detail Samsung has brought to the project gives us the confidence that the vials delivered to us are going to have material that is of high quality,” Ihle said. “What was also important to us was Samsung’s ability to start … when we needed to start, so that we didn’t have to wait for a few months for a slot to become available.”
In March, Samsung Biologics announced the construction of Plant 5 to commence further capacity expansion on Bio Campus II. The announcement has inspired Ihle and his team at Bolt Biotherapeutics to envision future partnerships built on confidence.
“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,” he said. “We are very hopeful for a long and positive future together with Samsung Biologics.”
In a partnership centered around saving lives, transparency between collaborators is paramount, as a minuscule miscommunication could cause a critical quality issue to a vial meant to be injected into a patient’s body. Since its founding in 2011, Samsung Biologics has maintained a flawless track record of delivering the highest quality service to clients when they need it, on schedule, and under full transparency. For more information on our end-to-end drug development services, please reach out to our experts at samsungbiologics.com/contact-us.
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How Samsung Biologics fostered a collaborative and transparent environment to meet a client’s time-sensitive project deadline
Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics
A fundamental consideration when a biotech company seeks to outsource its project from cell line development to Investigational New Drug (IND) submission is the selection of a CDMO partner who can offer transparency and find innovative solutions.
Open communication between a biotech and CDMO forges a trusted partnership, enables close collaboration, and facilitates timely problem-solving, ultimately leading to end-goal success. This was the case for Bolt Biotherapeutics Inc., which needed a competitive CDMO partner to help advance its molecules to IND filing within a condensed timeline.
“Transparency in a partnership is extremely important because it allows us to have confidence in what we are receiving from our CDMO partner,” said Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics. “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.”
Creating the best solution through transparent collaboration
Bolt is a clinical-stage biotechnology company committed to developing new medicines to address key unmet medical needs for cancer patients. The California-based biotech company is developing a myeloid modulating agonist antibody (BDC-3042) that could potentially convert tumor-supportive white blood cells, or macrophages, into ones that kill tumors.
Bolt hopes to gain authorization to begin testing its antibody in clinical trials as soon as possible and has partnered with Samsung Biologics to accelerate the execution of its early-phase drug development for IND submission.
To deliver on its client’s needs, Samsung Biologics proposed a 12-month timeline from cell line development to IND filing.
“Any CDMO could propose a very fast timeline,” Ihle said. “But if it wasn’t logical, we wouldn’t trust the CDMO. What Samsung proposed was fast but believable.”
While executing the project, however, there was a hurdle that could delay the timeline. During the process development phase, an unexpected impurity was detected, and an additional purification column was needed to ensure the quality of the vials. Samsung Biologics and Bolt confronted the problem immediately, transparently shared each other’s concerns, and “talked through those in a collaborative problem-solving way,” Ihle said.
In a collective effort to bring creative solutions to the problem, Samsung Biologics shared its years of cumulative project know-how with processing purification using multiple columns, while Bolt shared its scientific and experimental knowledge. Both teams eventually managed to implement the extra-column purification process without delaying the project.
“This is why transparency is so important to me,” Ihle said. “It helps lead to successful execution and creating not just good enough solutions but the best solutions.”
Emboldening hope for successful drug development, envisioning future partnership
Successful teamwork driven by the transparent sharing of information between Samsung Biologics and Bolt ultimately led BDC-3042 to be filed for IND application on schedule with the United States Food and Drug Administration (US FDA).
When asked to describe the moment he first learned of the successful completion of the drug-development project, Ihle summed it up in one word.
“It’s hopefulness,” he said. “We invested so much effort and passion into the project. And getting to the point of actually having the high-quality drug in a vial ready to administer to patients brings us hope that one day, our drugs that Samsung is manufacturing for us will save lives.”
For a CDMO to carry out an accelerated end-to-end drug development project, it requires technical expertise and experience as well as the capacity that enables the CDMO to readily provide services to its clients when they need them.
“The amount of attention to detail Samsung has brought to the project gives us the confidence that the vials delivered to us are going to have material that is of high quality,” Ihle said. “What was also important to us was Samsung’s ability to start … when we needed to start, so that we didn’t have to wait for a few months for a slot to become available.”
In March, Samsung Biologics announced the construction of Plant 5 to commence further capacity expansion on Bio Campus II. The announcement has inspired Ihle and his team at Bolt Biotherapeutics to envision future partnerships built on confidence.
“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,” he said. “We are very hopeful for a long and positive future together with Samsung Biologics.”
In a partnership centered around saving lives, transparency between collaborators is paramount, as a minuscule miscommunication could cause a critical quality issue to a vial meant to be injected into a patient’s body. Since its founding in 2011, Samsung Biologics has maintained a flawless track record of delivering the highest quality service to clients when they need it, on schedule, and under full transparency. For more information on our end-to-end drug development services, please reach out to our experts at samsungbiologics.com/contact-us.
Related contents
Our Services Development Services
Samsung BIO Insight Building a transformative partnership in drug development