Powering progress through partnership: CDMO collaboration for fast-tracked success
How Samsung Biologics supported a Canadian biopharmaceutical company
in attaining two clinical approvals of recombinant proteins
Thomas Loisel, left, Vice President of Manufacturing at 35Pharma,
and Jenna Ries, right, Project Manager of Manufacturing Operations at 35Pharma
35Pharma specializes in bringing novel biologic therapeutics from concept to clinic—rapidly, safely, and strategically. Success depends on the integration of scientific expertise and adaptable infrastructure, all rooted in a robust quality system.
That is why 35Pharma partnered with Samsung Biologics, a global contract development and manufacturing organization (CDMO), known for its proven track record, operational excellence, and strong commitment to client success. Together, they tackled the challenges of developing and manufacturing two complex therapeutic candidates—delivering results through tight coordination, shared accountability, and mutual trust.
“Samsung Biologics’ expertise and experience lie in its quality-by-design approaches and systematic risk assessments, which allowed us to accelerate our product development while maintaining confidence in both performance and scalability of manufacturing,” said Thomas Loisel, Vice President of Manufacturing at 35Pharma. “It was clear from the outset that Samsung Biologics had a roadmap for drug development, from process development and technology transfer to project management and quality analytics. Having all these groups synchronize together made our timelines fast and efficient.”
This collaboration showcases what is possible when the right strategy meets the right partner: accelerated development, rigorous execution, and a shared victory on the road to approval.
Overcoming challenges as a team
35Pharma is a clinical-stage biopharmaceutical company, located in Montreal, committed to developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity, and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology, combined with superior protein engineering, to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta superfamily ligands while sparing beneficial homeostatic ligands.
On a mission to find more effective and accessible treatments for diseases that impact millions of patients worldwide, 35Pharma partnered with Samsung Biologics to accelerate the development of its recombinant protein candidates, HS135 and HS235.
The 35Pharma-Samsung Biologics partnership obtained clinical trial approvals from the U.S. Food and Drug Administration (FDA) and Health Canada— key milestones on a complex development path. Novel biologic development rarely follows a straight line, but both teams were prepared for any unexpected circumstances. Grounded in a strong chemistry, manufacturing, and controls (CMC) strategy, open communication, and agile execution, they navigated every challenge with precision and speed. “Having transparent dialogue and a partner ready to adapt made all the difference in staying on track,” Loisel said.
One of the most significant challenges arose early on in 35Pharma’s development of its first product, HS135. “The molecule’s complex glycosylated structures had to be closely monitored throughout cell line development, requiring careful evaluation of both culture performance and product quality to ensure a robust clone was selected for manufacturing,” said Jenna Ries, Project Manager of Manufacturing Operations at 35Pharma. Understanding the inherent risks associated with the molecule’s structure, Samsung Biologics implemented a quality-driven cell line development method, which incorporated targeted glycan evaluation at key stages to accommodate the unique characteristics of a complex biologic.
Samsung Biologics leveraged its flexible resources to provide a customized approach to cell line development that matched 35Pharma’s product quality requirements for increased protein sialylation. To achieve this, Samsung Biologics deployed high-throughput lectin assays, enabling early-stage selection of recombinant protein candidates that exhibited elevated sialic acid content.
“Samsung Biologics’ platform capabilities and scientific insight complemented our understanding of the recombinant proteins,” said Loisel. “Having a CDMO that understands the nuances of glycoproteins from the outset of development and offers the right assets and expertise was a key element in our decision to partner with Samsung Biologics.”
The result was the successful development of a stable and viable cell line, which enabled the team to advance confidently through process and formulation development of HS135, ultimately reaching small-scale GMP manufacturing of the product before clinical trial application (CTA) filing with Health Canada.
Equally important to robust development methods in CMC is thorough and timely documentation. As an agile CDMO, Samsung Biologics prepared a large volume of records, such as product characterization reports, process control strategy, manufacturing batch records, and stability protocols, which were all necessary for 35Pharma to bring its product to clinical trials.
Analytical data was collected throughout the project, from early-stage development to GMP batch release. To save time and resources for the client, a thorough method qualification must be conducted to ensure that manufacturing scale-up can be achieved without compromising quality, explained Jihye Park, Senior Quality Analyst at Samsung Biologics.
“Because the filing schedule for HS135 was on a fast-paced timeline, we needed to maintain close communication with the client, so that the work—from design to documentation—was done right the first time,” said Park. “We were able to achieve these goals thanks to prompt responses to our inquiries, and more importantly, support from Team 35Pharma.”
Regardless of the time of day or night, various teams at Samsung Biologics worked diligently behind the scenes to expedite the manufacturing and release required for 35Pharma to meet its regulatory timelines.
“Quality actions go beyond what is captured in a quality management system or standard operating procedure,” Loisel said. “Samsung Biologics team members incorporated quality into their work at every step, which was regularly observed by our project group. This to me is an element of demonstrating that quality is really built in the Samsung Biologics team.”
Overcoming CMC challenges as a team created “a stronger sense of partnership and trust,” he said.
Another project, another approval through trusted partnership
The trust developed over the course of the HS135 program led 35Pharma to extend its partnership with Samsung Biologics, tasking the CDMO with advancing a second recombinant candidate, HS235, toward clinical approval.
Armed with experience of and insight into navigating the complexities of HS135, the 35Pharma-Samsung Biologics team was able to expedite the development pathway for HS235, achieving clinical approval from Health Canada for both molecules in less than a year.
“Trust is something that has to be built, and a testament to that trust is that 35Pharma signed on a second project with Samsung Biologics,” said Ries. “Through the first project, we saw how well the teams worked together, and that trust was solidified.”
The spirit of partnership and trust is at the heart of how this global CDMO ensures client satisfaction. Whether supporting traditional antibodies or pioneering emerging modalities, the Samsung Biologics team remains committed to offering tailored CMC strategies to advance every client’s molecule toward successful regulatory approval—with quality and agility leading the way.
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How Samsung Biologics supported a Canadian biopharmaceutical company in attaining two clinical approvals of recombinant proteins
Thomas Loisel, left, Vice President of Manufacturing at 35Pharma, and Jenna Ries, right, Project Manager of Manufacturing Operations at 35Pharma
35Pharma specializes in bringing novel biologic therapeutics from concept to clinic—rapidly, safely, and strategically. Success depends on the integration of scientific expertise and adaptable infrastructure, all rooted in a robust quality system.
That is why 35Pharma partnered with Samsung Biologics, a global contract development and manufacturing organization (CDMO), known for its proven track record, operational excellence, and strong commitment to client success. Together, they tackled the challenges of developing and manufacturing two complex therapeutic candidates—delivering results through tight coordination, shared accountability, and mutual trust.
“Samsung Biologics’ expertise and experience lie in its quality-by-design approaches and systematic risk assessments, which allowed us to accelerate our product development while maintaining confidence in both performance and scalability of manufacturing,” said Thomas Loisel, Vice President of Manufacturing at 35Pharma. “It was clear from the outset that Samsung Biologics had a roadmap for drug development, from process development and technology transfer to project management and quality analytics. Having all these groups synchronize together made our timelines fast and efficient.”
This collaboration showcases what is possible when the right strategy meets the right partner: accelerated development, rigorous execution, and a shared victory on the road to approval.
Overcoming challenges as a team
35Pharma is a clinical-stage biopharmaceutical company, located in Montreal, committed to developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity, and cardiometabolic diseases. 35Pharma leverages its scientific leadership in TGF-beta biology, combined with superior protein engineering, to discover innovative compounds that selectively and potently neutralize validated pathological TGF-beta superfamily ligands while sparing beneficial homeostatic ligands.
On a mission to find more effective and accessible treatments for diseases that impact millions of patients worldwide, 35Pharma partnered with Samsung Biologics to accelerate the development of its recombinant protein candidates, HS135 and HS235.
The 35Pharma-Samsung Biologics partnership obtained clinical trial approvals from the U.S. Food and Drug Administration (FDA) and Health Canada— key milestones on a complex development path. Novel biologic development rarely follows a straight line, but both teams were prepared for any unexpected circumstances. Grounded in a strong chemistry, manufacturing, and controls (CMC) strategy, open communication, and agile execution, they navigated every challenge with precision and speed. “Having transparent dialogue and a partner ready to adapt made all the difference in staying on track,” Loisel said.
One of the most significant challenges arose early on in 35Pharma’s development of its first product, HS135. “The molecule’s complex glycosylated structures had to be closely monitored throughout cell line development, requiring careful evaluation of both culture performance and product quality to ensure a robust clone was selected for manufacturing,” said Jenna Ries, Project Manager of Manufacturing Operations at 35Pharma. Understanding the inherent risks associated with the molecule’s structure, Samsung Biologics implemented a quality-driven cell line development method, which incorporated targeted glycan evaluation at key stages to accommodate the unique characteristics of a complex biologic.
Samsung Biologics leveraged its flexible resources to provide a customized approach to cell line development that matched 35Pharma’s product quality requirements for increased protein sialylation. To achieve this, Samsung Biologics deployed high-throughput lectin assays, enabling early-stage selection of recombinant protein candidates that exhibited elevated sialic acid content.
“Samsung Biologics’ platform capabilities and scientific insight complemented our understanding of the recombinant proteins,” said Loisel. “Having a CDMO that understands the nuances of glycoproteins from the outset of development and offers the right assets and expertise was a key element in our decision to partner with Samsung Biologics.”
The result was the successful development of a stable and viable cell line, which enabled the team to advance confidently through process and formulation development of HS135, ultimately reaching small-scale GMP manufacturing of the product before clinical trial application (CTA) filing with Health Canada.
Equally important to robust development methods in CMC is thorough and timely documentation. As an agile CDMO, Samsung Biologics prepared a large volume of records, such as product characterization reports, process control strategy, manufacturing batch records, and stability protocols, which were all necessary for 35Pharma to bring its product to clinical trials.
Analytical data was collected throughout the project, from early-stage development to GMP batch release. To save time and resources for the client, a thorough method qualification must be conducted to ensure that manufacturing scale-up can be achieved without compromising quality, explained Jihye Park, Senior Quality Analyst at Samsung Biologics.
“Because the filing schedule for HS135 was on a fast-paced timeline, we needed to maintain close communication with the client, so that the work—from design to documentation—was done right the first time,” said Park. “We were able to achieve these goals thanks to prompt responses to our inquiries, and more importantly, support from Team 35Pharma.”
Regardless of the time of day or night, various teams at Samsung Biologics worked diligently behind the scenes to expedite the manufacturing and release required for 35Pharma to meet its regulatory timelines.
“Quality actions go beyond what is captured in a quality management system or standard operating procedure,” Loisel said. “Samsung Biologics team members incorporated quality into their work at every step, which was regularly observed by our project group. This to me is an element of demonstrating that quality is really built in the Samsung Biologics team.”
Overcoming CMC challenges as a team created “a stronger sense of partnership and trust,” he said.
Another project, another approval through trusted partnership
The trust developed over the course of the HS135 program led 35Pharma to extend its partnership with Samsung Biologics, tasking the CDMO with advancing a second recombinant candidate, HS235, toward clinical approval.
Armed with experience of and insight into navigating the complexities of HS135, the 35Pharma-Samsung Biologics team was able to expedite the development pathway for HS235, achieving clinical approval from Health Canada for both molecules in less than a year.
“Trust is something that has to be built, and a testament to that trust is that 35Pharma signed on a second project with Samsung Biologics,” said Ries. “Through the first project, we saw how well the teams worked together, and that trust was solidified.”
The spirit of partnership and trust is at the heart of how this global CDMO ensures client satisfaction. Whether supporting traditional antibodies or pioneering emerging modalities, the Samsung Biologics team remains committed to offering tailored CMC strategies to advance every client’s molecule toward successful regulatory approval—with quality and agility leading the way.
Related Content
Samsung BIO Insight Bringing flexible solutions to champion shared commitment to saving lives
Samsung BIO Insight Forging a trusted partnership in end-to-end drug development
Samsung BIO Insight Building a transformative partnership in drug development
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