Samsung’s Latest Development Platforms
Samsung Biologics has recently launched new technology platforms. Can you explain the key features and benefits of these platforms?
Samsung Biologics continues to introduce new and innovative technology platforms with high-performing solutions that enhance therapeutic efficacy and proactively address evolving industry trends.
S-AfuCHO™ is a cell line platform that can generate afucosylated antibodies that exhibit enhanced antibody-dependent cellular cytotoxicity (ADCC) activity for increased therapeutic efficacy. The platform removes the core fucose from Fc N-glycans through knockout of the host (FUT8) gene to achieve higher ADCC activity while retaining desired titers, stability, and product quality.
S-OptiCharge™ is an upstream process platform that can modulate a molecule’s charge variant distribution. By optimizing media, additives, and process parameters and using a thorough screening procedure, the platform ensures high product quality through tight control over critical quality attributes to achieve optimal charge variant distribution.
S-Tensify™ technology platform represents a significant advancement in biopharmaceutical manufacturing. Unlike traditional fed-batch processes, S-Tensify™ utilizes intensified-fed-batch methods during the N-1 phase, incorporating perfusion to maintain optimal cell culture conditions. This process removes spent media while delivering essential nutrients to the cells, simultaneously removing inhibitory byproducts that accumulate during cellular metabolism. This enables the creation of a healthy environment that fosters a high density of viable cells. The process also utilizes an alternate tangential flow filtration system that retains the cells within the culture while exchanging the media, ensuring a high concentration of viable cells.
We will continue to develop innovative solutions to help enable high-quality development to meet the increased demand for complex and high-concentration biopharmaceuticals.
Flexible Contract Development Services
Samsung Biologics is also known for its flexible contract development services. Can you elaborate on how these services are tailored to meet the diverse needs of your clients and what sets them apart from other CDMOs in the industry?
Samsung Biologics offers agile and flexible development services designed to meet the diverse needs of clients. Our approach begins with a deep understanding of clients’ development goals and an in-depth analysis of their molecule type. We support this strategy with our advanced technological capabilities and innovative processes. SelecTailor™, our customizable development solutions, allow clients to choose their own tailored package—Simplified IND, Comprehensive IND, or Enhanced CMC*—to precisely meet their project requirements. Whether clients seek accelerated timelines, efficient costs, or enhanced quality, the design of each program ensures maximum flexibility as clients can fine-tune their programs by adding service options to align with their development goals.
Our proprietary development platforms, including S-CHOice®, S-DUAL™, and DEVELOPICK™, further enhance efficiency in critical areas such as cell line development and antibody production. These innovative platforms streamline processes, enabling faster drug development timelines from gene to IND submission.
Given the complexities and unpredictable nature of drug development, Samsung Biologics does its best to address diverse client needs during development by leveraging the expertise with a solid track record of success built in a short period. Additionally, building on our commitment to quality and speed, we map out potential risks from the initial stages and ensure that the development of our client’s products complies with all relevant regulatory standards while providing full transparency to clients along the way.
*Chemical, manufacturing, and control (CMC) activities are essential to drug development to meet quality, safety, and efficacy standards. It includes the development of manufacturing processes, quality control tests, and stability studies.
Strategic Move in the ADC Business
Samsung Biologics is making a strategic move into the antibody-drug conjugate (ADC) business. What motivated this decision, and how do you plan to leverage your existing capabilities to succeed in this growing market?
A key reason for Samsung Biologics’ strategic portfolio diversification into the antibody-drug conjugate (ADC) space is the growing demand for targeted cancer therapies and the company’s commitment to proactively address the needs of clients and ultimately help save people’s lives. ADCs are complex molecules that require precise and reliable manufacturing processes, areas where Samsung Biologics can leverage its existing expertise. We plan to offer comprehensive ADC services, from development to commercial production, building on our expertise in antibody engineering, process development, and large-scale manufacturing of antibodies.
We are currently constructing a standalone facility set for completion in 2024. This expansion will allow us to better cater to clients’ next-generation oncology pipelines and further solidify our position as a leading global CDMO.
Samsung Biologics also continues to invest in promising ADC biotech companies through the Samsung Life Science Fund to seek partnership opportunities and expand our capabilities.
End-to-End Service Integration
Your company offers end-to-end services from cell line development to commercial manufacturing. How does this integrated approach benefit your clients, particularly in terms of speed, cost, and quality?
Samsung Biologics offers end-to-end services, from late-stage development through commercial manufacturing, storage, and global distribution. We ensure a seamless transition between different stages of development and manufacturing to reduce handoff risks and accelerate project timelines. Clients benefit from having a single point of contact throughout the project life cycle, which allows efficient communication and project management. Samsung Biologics has scalability from a small scale – 1 kL – and can scale that up to 5 kL, 10 kL, and 15 kL, allowing clients to save on time and costs as our integrated plants can handle a product’s entire production life cycle. We enable our clients to take full advantage of our capacity and flexible operation capabilities. Samsung Biologics can also accommodate tech transfers within six months by leveraging experience with diverse and complex molecules to successfully identify, address, and eliminate risks at each stage.
We are also committed to quality at every stage so that clients receive consistent, high-quality products, ensuring the successful delivery of their therapies to patients. Samsung Biologics has achieved a 98% batch success rate and over 310 global regulatory approvals.
Client-Centric Approach
Samsung Biologics emphasizes a client-centric approach in its operations. Can you provide examples of how this approach has helped your clients achieve their development and manufacturing goals more effectively?
Samsung Biologics has received the CDMO Leadership Award for 11 consecutive years since 2013 in recognition of the company’s unwavering commitment to client satisfaction. Our pillars of excellence also drive the company’s client-centric operations:
- Customer Excellence: Focusing daily operations and business development plans on addressing client needs is what we do for client success.
- Operational Excellence: We have an ongoing commitment to optimizing processes and standardizing systems for efficiency, data integrity, and, ultimately, client satisfaction.
- Quality Excellence: Our quality mindset and culture ensure client programs stay compliant with evolving regulations. We also integrate quality by design principles to maintain robust data compliance, enabling the timely problem-solving of issues.
- People Excellence: We are committed to continuous learning and development to empower our scientists and staff to enhance innovation, efficiency, and customer satisfaction.
In terms of our services, our client-centric approach is evident in how we respond to critical challenges during development. When a client encounters an unforeseen issue that could impact their timeline, Samsung Biologics quickly engages in open communication and collaboration to address the problem. By drawing on our technical expertise and flexible production capabilities, we devise tailored solutions to mitigate risks and ensure the project stays on track. This proactive support exemplifies our commitment to delivering innovative, high-quality solutions that exceed client expectations and ensure project success.
Future Expansion Plans
With the continuous expansion of your facilities and services, what are Samsung Biologics’ plans to further enhance its capabilities and maintain its competitive edge in the biopharmaceutical market?
Samsung Biologics is dedicated to meeting the evolving needs of clients through cutting-edge development services and ensuring a stable supply of vital therapeutics. We do this by continuously expanding our capacity in addition to investing in innovation and technical capabilities. We broke ground on our second Bio Campus last year with the construction of a fifth plant. Upon completion in April 2025, Plant 5 will bring our total biomanufacturing capacity to 784 kL liters. By 2032, Bio Campus II will house a total of four plants, each with a capacity of 180 kL, and combined with Bio Campus I, Samsung Biologics will be able to offer over 1,324 kL of biomanufacturing capacity to clients worldwide to address shortages in the market for existing commercial products with increased demand or newly approved drugs that will require large-scale manufacturing in the coming years.
The company is also in a strong position to meet the needs of existing and potential clients with sales offices in New Jersey, San Francisco, and Boston. The offices allow our sales team to provide daily real-time interaction to build stronger and trusted relationships. We also continue to review geographical expansion to other areas of the U.S. and Europe to work in closer proximity to our clients.
In addition to mRNA and ADC services, Samsung Biologics continues to explore new modalities to align our business strategy with the current and future needs of our clients to support their pipelines.
Samsung Biologics also continues to build partnerships with both global pharma and emerging biotech companies by offering services that incorporate new proprietary platforms to better assess molecules, increase expression, enhance quality, and accelerate timelines.
Author Details
Brian Hosung Min, Executive Vice President and Head of CDO Development & Sales
Publication Details
This article appeared in American Pharmaceutical Review: Vol. 27, No. 6Sept/Oct 2024Pages: 80-81
Subscribe to our e-newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from American Pharmaceutical Review delivered to your inbox!
Sign up now!