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Harmonized toward ADC expertise
When Song Young Kim joined Samsung Biologics in 2023 as Process Development Director, antibody-drug conjugates (ADCs) had already been in the market for more than two decades, yet garnering attention once more for their targeted therapeutic effects and promising clinical applications. Now with over a dozen FDA-approved ADCs in the market and many more candidates, the biopharmaceutical industry is looking to scale up development and production of these high-quality biomedicines. Partnership with trusted contract development and manufacturing organizations (CDMOs) is ever more key.
Kim and his team are in charge of advancing ADC services at Samsung Biologics and setting up process development in the CDMO’s new ADC facility, to which they relocated in early February.
The cost of process development for linker-payload conjugation to the antibody moiety as well as specialized facilities for handling toxins can present a hurdle when manufacturing ADCs. The modality also requires analytical and formulation methods to accommodate their high hydrophobicity and low stability relative to monoclonal antibodies. ADCs can be unstable in the liquid state, for example. Triin Jurgenson, senior scientist in ADC process development in Kim’s team, puts it like this: “In order to produce more homogeneous ADCs, the conjugation process tends to become more complex.”
End-to-end
At Samsung Biologics, expertise in EPCV (engineering, procurement, construction, and validation) and prioritization of safety protocols for handling toxins, such as isolators and fume hoods, make for a smooth transition into the new venture.
Located across Bio Campuses I and II at in a separate location, the four-story standalone facility at Samsung Biologics allows for ADC conjugation right near where the antibodies are made. “It can be that at a given CDMO, the antibodies are manufactured separately, conjugation is carried out separately, and the drug product is made separately,” says Ryuryun Kim, lead scientist in ADC process development.
What ensure the quality, safety, and efficacy of ADCs, according to Thomas Rohrer, Senior Director of Technical Support for Bioconjugates, are meticulous analytical capability and a flexible manufacturing environment that can adapt to the changing conjugation chemistries required in the next generation of ADCs. “Samsung Biologics has the ability to engineer the targeting agent to improve the specificity, ADCC response, and homogeneity of the ADC,” he says.
Based in Washington D.C. and working with the Samsung Biologics America team in New Jersey and the campus in Songdo, Rohrer envisions a “one-stop shop.” He believes such a vision is possible with Samsung Biologics’ new ADC facility, with process development and manufacturing experience paired with advanced analytical services to support ambitious timelines for drug product delivery. World-class analytical technology for characterization and stability complements ADC drug substance and product manufacturing capability.
Driven by this shared goal, the Samsung Biologics ADC team has been setting up experiments around the clock to kick-start prospective clients’ projects, run validations, and study standard operating procedures to determine feasibility. The global CDMO has the ability to perform stability analyses of the drug substance and drug product to ensure that ADCs maintain their integrity and efficacy from early clinical phase to commercial manufacturing. Comprehensive analytical techniques allow the team to identify the structural robustness and monitor intermediate samples from process development and manufacturing.
One Team
Senior scientist in ADC analytical development Seokho Hong commends his team members for fostering a healthy, collaborative work culture. “The patient-centric fabric of Samsung Biologics enables the collective persistence necessary for overcoming the challenges of not only setting up a new laboratory environment, but also meeting the needs of clients with varying ADC project needs,” he says.
Understanding of specific client needs enabled by skilled project management harmonize the ADC team and Samsung Biologics at large. Details of each project are orchestrated to combat any gaps in scheduling, which ensures timelines are met without exception.
This patient-centric mindset throughout the company translates to securing promising partnerships. Joseph Jeong, Vice President and Head of ADC Development, knows that a strong CDMO partner understands the client’s specific technical needs from the bottom up. “By catching onto a detail that a prospective client mentions in passing mid-discussion, we demonstrate that we can be trusted to deliver on complex projects,” he says.
Conversations like these drive Jeong and his team to embrace the durable mindset of a craftsman, undeterred by whatever challenges may lie ahead. From enzyme-mediate conjugation and engineered antibody conjugation to glycan-bridge conjugation, the Samsung Biologics team is continuing to equip itself with robust technological experience.
“Starting my career in biotechnology at the National Cancer Institute, I observed the debilitating side effects of systemic chemotherapy first-hand and wanted to enable the scientists developing therapies to offer a targeted therapeutic approach,” Rohrer says.
To achieve the therapeutic potential ADCs offer the right targeting agent, linker and payload combination is critical. “ADCs must have stability in circulation and release their payload upon binding and internalization into the target tissue,” Rohrer says. “Optimal ADC dose for patients might vary based on factors like antigen density, tumor size, and immune response.” Having started work with ADCs at the turn of the millennium, Rohrer is driven by the promise targeted therapeutics bring to cancer treatment.
And so is Song Young Kim. “This opportunity is a new adventure for the whole company to continue growing toward capabilities beyond antibody manufacturing,” he says. “But perhaps more importantly, it is our responsibility to patients and society at large that ultimately drives us toward improving the quality of life around the world.”
Related Contents
Our Sevices Antibody-Drug Conjugates (ADC)
Samsung BIO Insights Innovation towards next-generation therapeutics
Posters Streamlining ADC development and manufacturing through new strategic capabilities
Webinars Manufacturing concepts for antibody-drug conjugates
When Song Young Kim joined Samsung Biologics in 2023 as Process Development Director, antibody-drug conjugates (ADCs) had already been in the market for more than two decades, yet garnering attention once more for their targeted therapeutic effects and promising clinical applications. Now with over a dozen FDA-approved ADCs in the market and many more candidates, the biopharmaceutical industry is looking to scale up development and production of these high-quality biomedicines. Partnership with trusted contract development and manufacturing organizations (CDMOs) is ever more key.
Kim and his team are in charge of advancing ADC services at Samsung Biologics and setting up process development in the CDMO’s new ADC facility, to which they relocated in early February.
The cost of process development for linker-payload conjugation to the antibody moiety as well as specialized facilities for handling toxins can present a hurdle when manufacturing ADCs. The modality also requires analytical and formulation methods to accommodate their high hydrophobicity and low stability relative to monoclonal antibodies. ADCs can be unstable in the liquid state, for example. Triin Jurgenson, senior scientist in ADC process development in Kim’s team, puts it like this: “In order to produce more homogeneous ADCs, the conjugation process tends to become more complex.”
End-to-end
At Samsung Biologics, expertise in EPCV (engineering, procurement, construction, and validation) and prioritization of safety protocols for handling toxins, such as isolators and fume hoods, make for a smooth transition into the new venture.
Located across Bio Campuses I and II at in a separate location, the four-story standalone facility at Samsung Biologics allows for ADC conjugation right near where the antibodies are made. “It can be that at a given CDMO, the antibodies are manufactured separately, conjugation is carried out separately, and the drug product is made separately,” says Ryuryun Kim, lead scientist in ADC process development.
What ensure the quality, safety, and efficacy of ADCs, according to Thomas Rohrer, Senior Director of Technical Support for Bioconjugates, are meticulous analytical capability and a flexible manufacturing environment that can adapt to the changing conjugation chemistries required in the next generation of ADCs. “Samsung Biologics has the ability to engineer the targeting agent to improve the specificity, ADCC response, and homogeneity of the ADC,” he says.
Based in Washington D.C. and working with the Samsung Biologics America team in New Jersey and the campus in Songdo, Rohrer envisions a “one-stop shop.” He believes such a vision is possible with Samsung Biologics’ new ADC facility, with process development and manufacturing experience paired with advanced analytical services to support ambitious timelines for drug product delivery. World-class analytical technology for characterization and stability complements ADC drug substance and product manufacturing capability.
Driven by this shared goal, the Samsung Biologics ADC team has been setting up experiments around the clock to kick-start prospective clients’ projects, run validations, and study standard operating procedures to determine feasibility. The global CDMO has the ability to perform stability analyses of the drug substance and drug product to ensure that ADCs maintain their integrity and efficacy from early clinical phase to commercial manufacturing. Comprehensive analytical techniques allow the team to identify the structural robustness and monitor intermediate samples from process development and manufacturing.
One Team
Senior scientist in ADC analytical development Seokho Hong commends his team members for fostering a healthy, collaborative work culture. “The patient-centric fabric of Samsung Biologics enables the collective persistence necessary for overcoming the challenges of not only setting up a new laboratory environment, but also meeting the needs of clients with varying ADC project needs,” he says.
Understanding of specific client needs enabled by skilled project management harmonize the ADC team and Samsung Biologics at large. Details of each project are orchestrated to combat any gaps in scheduling, which ensures timelines are met without exception.
This patient-centric mindset throughout the company translates to securing promising partnerships. Joseph Jeong, Vice President and Head of ADC Development, knows that a strong CDMO partner understands the client’s specific technical needs from the bottom up. “By catching onto a detail that a prospective client mentions in passing mid-discussion, we demonstrate that we can be trusted to deliver on complex projects,” he says.
Conversations like these drive Jeong and his team to embrace the durable mindset of a craftsman, undeterred by whatever challenges may lie ahead. From enzyme-mediate conjugation and engineered antibody conjugation to glycan-bridge conjugation, the Samsung Biologics team is continuing to equip itself with robust technological experience.
“Starting my career in biotechnology at the National Cancer Institute, I observed the debilitating side effects of systemic chemotherapy first-hand and wanted to enable the scientists developing therapies to offer a targeted therapeutic approach,” Rohrer says.
To achieve the therapeutic potential ADCs offer the right targeting agent, linker and payload combination is critical. “ADCs must have stability in circulation and release their payload upon binding and internalization into the target tissue,” Rohrer says. “Optimal ADC dose for patients might vary based on factors like antigen density, tumor size, and immune response.” Having started work with ADCs at the turn of the millennium, Rohrer is driven by the promise targeted therapeutics bring to cancer treatment.
And so is Song Young Kim. “This opportunity is a new adventure for the whole company to continue growing toward capabilities beyond antibody manufacturing,” he says. “But perhaps more importantly, it is our responsibility to patients and society at large that ultimately drives us toward improving the quality of life around the world.”
Related Contents
Our Sevices Antibody-Drug Conjugates (ADC)
Samsung BIO Insights Innovation towards next-generation therapeutics
Posters Streamlining ADC development and manufacturing through new strategic capabilities
Webinars Manufacturing concepts for antibody-drug conjugates