From challenges to success: How Samsung Biologics drives client collaboration to accelerate time-sensitive technology transfers
Collaboration in biopharmaceutical manufacturing expedites timelines, ensures batch consistency, and enables the on-time delivery of life-saving medicines.
When global pharmaceutical companies race to bring essential treatments to patients, every day counts. Weeks saved in manufacturing mean earlier patient access, greater market share, and a stronger competitive edge. At Samsung Biologics, end-to-end collaboration—with aligned teams, integrated processes, and clear communication—has been proven to accelerate technology transfers while maintaining consistent quality across batches.
In one project, a global pharmaceutical client required millions of vials within a compressed timeline. By coordinating at every stage of the process, Samsung Biologics streamlined technical workflows, mitigated risks, and delivered on schedule.
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“In this industry, timelines define success.
By aligning our teams and working closely with clients, we ensure batch-to-batch consistency while accelerating every step of the tech transfer.”
David King | Senior Director, Samsung Biologics DP Team
Accelerating technology transfers and operations
From the outset, speed drove every decision. The client required a manufacturing timeline nearly twice as fast as the industry standard. As the drug addressed an urgent public health need, being first to market was critical.
The collaboration relied on two principles: integration and communication. With both drug substance (DS) and drug product (DP) manufacturing under one roof, materials were preserved within a unified quality system, thereby eliminating delays tied to shipping, external testing, and third-party risks. Conditional release allowed basic safety tests—including endotoxin and bioburden—to be run in-house, enabling DP filling to begin while full DS testing was still underway. This overlap shaved weeks from the timeline.
The client provided a steady flow of technical data and requirements. Samsung Biologics processed this information, conducted gap assessments, and reconvened to set targets and create mitigation strategies. When one approach risked delay, the alternatives ensured flexibility and rapid problem-solving.
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Automatic visual inspection presented a major technical hurdle. Manual inspection could check two to three vials per minute, while machines could process up to 300. Implementing inspection recipes, defect kits, and machine parameters carries inherent risk, so Samsung Biologics coordinated client experts, equipment vendors, defect kit manufacturers, and internal subject matter experts on-site. This one-team approach facilitated immediate protocol amendments and approvals, leaving no gaps in execution.
The outcomes were expedited technology transfers, regulatory compliance, and the on-time delivery of 40 batches and 10 million vials.
Building on collaboration for the future
Lessons learned became the foundation for continuous improvements across the Samsung Biologics DP team. Tight project coordination strengthened teamwork, enhanced technical capabilities, and fostered a culture of proactive problem-solving.
Disciplined collaboration elevated the entire organization. By establishing clear goals, fostering open communication, and enforcing accountability, the DP team learned to anticipate challenges and act decisively. Scientists involved in the project, such as Hyeongyu Ryu, sharpened their skills in managing complex technical demands and delivering results under pressure.
.webp)
Technical expertise also proved crucial. Automatic visual inspection underscored the value of in-depth knowledge of equipment and methodology.
Drawing on the insights of experts such as Mitsutaka Shirasaki, the DP team continues to refine inspection processes, optimize workflows, and develop advanced methodologies. This collaborative learning improves the team’s ability to handle future client challenges, ensuring complex projects proceed efficiently and reliably.
.webp)
Together, these lessons reinforce the DP team’s approach: operational excellence paired with technical expertise and proactive problem-solving strengthened by collaborative agility. The team stands ready to handle urgent, high-stakes projects with confidence.
The anatomy of end-to-end collaboration
End-to-end collaboration combines technical rigor with trust. Integration keeps DS and DP under a single quality system, allowing conditional DS releases to feed directly into DP production. In-house quality control testing removes third-party delays, enabling rapid corrective actions and root-cause investigations.
From the outset, the DP team aligns with client goals, ensuring transparent communication, shared decision-making, and clear accountability. Such collaboration accelerates timelines, maintains batch quality, and resolves issues quickly.
.webp)
“Trust grows step by step with each decision and open discussion. That trust became fundamental to our end-to-end collaboration and enabled the success of the project,” King said.
As time-sensitive therapeutics continue to shape the biopharmaceutical industry, Samsung Biologics recognizes that collaboration must begin at an introductory meeting with clients and continue until final products are delivered on time. By combining integrated facilities, rigorous execution, and transparent client interactions, the leading CDMO transforms biopharmaceutical challenges into manufacturing success—and achieves client satisfaction.
Related content
Webinars Accelerated tech transfer with integrated, client-focused project management
Whitepapers Advancing drug product quality through automated visual inspection and future ready infrastructure
Samsung BIO Insight Cascading excellence: How Samsung Biologics fosters CMC expertise and achieves client satisfaction
Collaboration in biopharmaceutical manufacturing expedites timelines, ensures batch consistency, and enables the on-time delivery of life-saving medicines.
When global pharmaceutical companies race to bring essential treatments to patients, every day counts. Weeks saved in manufacturing mean earlier patient access, greater market share, and a stronger competitive edge. At Samsung Biologics, end-to-end collaboration—with aligned teams, integrated processes, and clear communication—has been proven to accelerate technology transfers while maintaining consistent quality across batches.
In one project, a global pharmaceutical client required millions of vials within a compressed timeline. By coordinating at every stage of the process, Samsung Biologics streamlined technical workflows, mitigated risks, and delivered on schedule.
.webp)
“In this industry, timelines define success. By aligning our teams and working closely with clients, we ensure batch-to-batch consistency while accelerating every step of the tech transfer.” - David King | Senior Director, Samsung Biologics DP Team
Accelerating technology transfers and operations
From the outset, speed drove every decision. The client required a manufacturing timeline nearly twice as fast as the industry standard. As the drug addressed an urgent public health need, being first to market was critical.
The collaboration relied on two principles: integration and communication. With both drug substance (DS) and drug product (DP) manufacturing under one roof, materials were preserved within a unified quality system, thereby eliminating delays tied to shipping, external testing, and third-party risks. Conditional release allowed basic safety tests—including endotoxin and bioburden—to be run in-house, enabling DP filling to begin while full DS testing was still underway. This overlap shaved weeks from the timeline.
The client provided a steady flow of technical data and requirements. Samsung Biologics processed this information, conducted gap assessments, and reconvened to set targets and create mitigation strategies. When one approach risked delay, the alternatives ensured flexibility and rapid problem-solving.
Automatic visual inspection presented a major technical hurdle. Manual inspection could check two to three vials per minute, while machines could process up to 300. Implementing inspection recipes, defect kits, and machine parameters carries inherent risk, so Samsung Biologics coordinated client experts, equipment vendors, defect kit manufacturers, and internal subject matter experts on-site. This one-team approach facilitated immediate protocol amendments and approvals, leaving no gaps in execution.
The outcomes were expedited technology transfers, regulatory compliance, and the on-time delivery of 40 batches and 10 million vials.
Building on collaboration for the future
Lessons learned became the foundation for continuous improvements across the Samsung Biologics DP team. Tight project coordination strengthened teamwork, enhanced technical capabilities, and fostered a culture of proactive problem-solving.
Disciplined collaboration elevated the entire organization. By establishing clear goals, fostering open communication, and enforcing accountability, the DP team learned to anticipate challenges and act decisively. Scientists involved in the project, such as Hyeongyu Ryu, sharpened their skills in managing complex technical demands and delivering results under pressure.
Technical expertise also proved crucial. Automatic visual inspection underscored the value of in-depth knowledge of equipment and methodology.
Drawing on the insights of experts such as Mitsutaka Shirasaki, the DP team continues to refine inspection processes, optimize workflows, and develop advanced methodologies. This collaborative learning improves the team’s ability to handle future client challenges, ensuring complex projects proceed efficiently and reliably.
Together, these lessons reinforce the DP team’s approach: operational excellence paired with technical expertise and proactive problem-solving strengthened by collaborative agility. The team stands ready to handle urgent, high-stakes projects with confidence.
The anatomy of end-to-end collaboration
End-to-end collaboration combines technical rigor with trust. Integration keeps DS and DP under a single quality system, allowing conditional DS releases to feed directly into DP production. In-house quality control testing removes third-party delays, enabling rapid corrective actions and root-cause investigations.
From the outset, the DP team aligns with client goals, ensuring transparent communication, shared decision-making, and clear accountability. Such collaboration accelerates timelines, maintains batch quality, and resolves issues quickly.
“Trust grows step by step with each decision and open discussion. That trust became fundamental to our end-to-end collaboration and enabled the success of the project,” King said.
As time-sensitive therapeutics continue to shape the biopharmaceutical industry, Samsung Biologics recognizes that collaboration must begin at an introductory meeting with clients and continue until final products are delivered on time. By combining integrated facilities, rigorous execution, and transparent client interactions, the leading CDMO transforms biopharmaceutical challenges into manufacturing success—and achieves client satisfaction.
Related content
Webinars Accelerated tech transfer with integrated, client-focused project management
Whitepapers Advancing drug product quality through automated visual inspection and future ready infrastructure
Samsung BIO Insight Cascading excellence: How Samsung Biologics fosters CMC expertise and achieves client satisfaction
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