The demand for biologics continues to grow alongside the need for complex modalities, such as antibody-drug conjugates and multispecific antibodies, which serve as advanced therapeutics. However, the requisite agility and biomanufacturing standardization are often an afterthought, resulting in delays in project decisions or onboarding due to the complexities of unfamiliar systems, equipment, or operators.
Built on Expertise
Built on Samsung Biologics’ extensive manufacturing expertise and proven process know-how, ExellenS™ applies optimized bioreactor configurations and production parameters tailored to each molecule’s specific requirements. ExellenS™ also unifies digital platforms, integrating predictive automation into globally harmonized systems and enhancing data compliance to improve process efficiency. As a result, clients benefit from greater speed and the assurance of the highest data integrity standards across every batch, along with uninterrupted and integrated production during scale-up.
“While core systems, such as bioreactors and chromatography columns, remain consistent, advanced digitalization and automation are implemented with ExellenS™ for seamless scale-up,” says Pierre Catignol, Executive Vice President and Head of Operation.
Real-time performance visibility boosts client confidence in every quality outcome. Data-backed decision-making enhances process efficiency and allows clients to model best possible scenarios to accelerate the path to commercialization.
Designed for Speed
A unified partnership experience revolves around flexibility, and ExellenS™ promises that every plant, process, and partnership will be handled with the same precision to give clients confidence in production quality across Samsung Biologics sites.
In addition, Samsung Biologics’ standardized bioreactor configuration acts as an extension of each client’s manufacturing network. This replicated manufacturing framework, which includes equivalent processes and equipment, reduces the risk of delay or the need for extensive revalidation.
Standardized for Reliability
Samsung Biologics upholds a commitment to reliable partnerships, powered by ExellenS™, its optimized biomanufacturing framework. Plant equivalency lays the groundwork for fast technology transfers, ensuring the efficiency needed to overcome challenges in project execution.
With a track record of global regulatory compliance over the years, Samsung Biologics demonstrates the consistent quality that drives its industry-leading batch success rate of over 99%. “Built on our cumulative expertise and manufacturing know-how, ExellenS™ drives this track record forward as we look to the future and continuously add value for our clients,” says Diane Black, Executive Vice President and Chief Quality Officer at Samsung Biologics.
Samsung Biologics’ flexibility extends to accommodating evolving pipelines. “Multi-sourcing maximizes flexibility in scheduling by having the same products manufactured in multiple plants,” says Kevin Sharp, Executive Vice President and Head of Sales and Operation. “Dual downstream capabilities also optimize the efficiency in manufacturing multispecific antibodies and newer modalities.”
Rotating production simplifies internal technology transfers between Samsung Biologics plants while guaranteeing consistent outcomes. “When the process and quality controls are standardized, we can replicate the plant anywhere in the world and achieve equivalent performance,” says Sangwon Seo, Vice President and Head of Engineering and Facilities. “Location is no longer a limiting factor.”
Track Record of Meeting Partner Expectations
Samsung Biologics’ client-first culture sets the standard for quality in communications, teamwork, and shared vision. ExellenS™ delivers on the promise of reliable excellence in biomanufacturing to meet partner expectations.
By executing technology transfers at speed while ensuring that quality remains at the forefront of therapeutic innovation, Samsung Biologics employs its state-of-the-art facilities to manufacture products interchangeably between sites and ensure that patients receive the right products, at the right time.
“A proven track record and digital intelligence are the backbone of our promise to meet an optimized manufacturing standard around the world,” says James Choi, Executive Vice President and Head of Sales Support. “Our culture of excellence, deeply embedded within the company, ensures that our clients benefit from an ecosystem designed for long-term pipeline growth.”
The demand for biologics continues to grow alongside the need for complex modalities, such as antibody-drug conjugates and multispecific antibodies, which serve as advanced therapeutics. However, the requisite agility and biomanufacturing standardization are often an afterthought, resulting in delays in project decisions or onboarding due to the complexities of unfamiliar systems, equipment, or operators.
Built on Expertise
Built on Samsung Biologics’ extensive manufacturing expertise and proven process know-how, ExellenS™ applies optimized bioreactor configurations and production parameters tailored to each molecule’s specific requirements. ExellenS™ also unifies digital platforms, integrating predictive automation into globally harmonized systems and enhancing data compliance to improve process efficiency. As a result, clients benefit from greater speed and the assurance of the highest data integrity standards across every batch, along with uninterrupted and integrated production during scale-up.
“While core systems, such as bioreactors and chromatography columns, remain consistent, advanced digitalization and automation are implemented with ExellenS™ for seamless scale-up,” says Pierre Catignol, Executive Vice President and Head of Operation.
Real-time performance visibility boosts client confidence in every quality outcome. Data-backed decision-making enhances process efficiency and allows clients to model best possible scenarios to accelerate the path to commercialization.
Designed for Speed
In addition, Samsung Biologics’ standardized bioreactor configuration acts as an extension of each client’s manufacturing network. This replicated manufacturing framework, which includes equivalent processes and equipment, reduces the risk of delay or the need for extensive revalidation.
Standardized for Reliability
With a track record of global regulatory compliance over the years, Samsung Biologics demonstrates the consistent quality that drives its industry-leading batch success rate of over 99%. “Built on our cumulative expertise and manufacturing know-how, ExellenS™ drives this track record forward as we look to the future and continuously add value for our clients,” says Diane Black, Executive Vice President and Chief Quality Officer at Samsung Biologics.
Samsung Biologics’ flexibility extends to accommodating evolving pipelines. “Multi-sourcing maximizes flexibility in scheduling by having the same products manufactured in multiple plants,” says Kevin Sharp, Executive Vice President and Head of Sales and Operation. “Dual downstream capabilities also optimize the efficiency in manufacturing multispecific antibodies and newer modalities.”
Track Record of Meeting Partner Expectations
By executing technology transfers at speed while ensuring that quality remains at the forefront of therapeutic innovation, Samsung Biologics employs its state-of-the-art facilities to manufacture products interchangeably between sites and ensure that patients receive the right products, at the right time.
“A proven track record and digital intelligence are the backbone of our promise to meet an optimized manufacturing standard around the world,” says James Choi, Executive Vice President and Head of Sales Support. “Our culture of excellence, deeply embedded within the company, ensures that our clients benefit from an ecosystem designed for long-term pipeline growth.”
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