Contract development and manufacturing organization (CDMO) Samsung Biologics has built a reputation for producing monoclonal antibodies, but the CDMO recently launched a new platform to work in the burgeoning field of bispecific antibodies.
While monoclonal antibodies continue to play an important role in many therapeutics, they can only bind to one antigen. On the other hand, bispecific antibodies have the capacity to bind to two different antigens, leaving them better equipped to address a range of conditions.
They’re currently being developed for promising applications in oncology. For example, bispecific antibodies can link cancer cells to immune cells like T-cells, effectively directing the body’s immune response toward the tumor. This method, known as redirected T-cell cytotoxicity, has shown remarkable results in treating some types of cancer, including leukemia.
Samsung Biologics’ new S-KiH platform is designed to develop and manufacture bispecific antibodies with “knob-in-hole” technology, which is used to modify the structure of antibodies so they can pair more effectively with each other. It ensures that two different parts of an antibody come together to form a stable bispecific antibody.
“Since knob-in-hole (KiH) BsAbs are composed of two distinct heavy and light chains (or two distinct heavy chains and common light chains), multiple final forms can arise during their assembly,” explained a veteran cell line development scientist at Samsung Biologics, in a recent article.
“The mispairing of heavy and light chains can lead to unwanted impurities that are difficult to remove due to their similarity to the desirable form. Therefore, consistent production of structurally complex molecules that exhibit high yield and purity, with commercialization in mind, requires keen expertise and experience.”
How S-KiH Works
Samsung Biologics built the S-KiH platform to improve heterodimer formation, which refers to the process of pairing two different molecules.
“Recognizing the demand for improved bispecific antibodies, Samsung Biologics devised a strategy to elevate the heterodimer formation rate by minimizing product-based impurities. This approach highlights the benefits of a streamlined production process and maximizes the benefits of single-cell production,” wrote Woosuk Jung, a lead scientist of the Antibody Technology Lab at Samsung Biologics, in a recent white paper.
“After comprehensive experimentation, we achieved a remarkable over 85% heterodimer formation rate, which surpasses conventional KiH technology by over 10%. This breakthrough not only improves titers, but also ensures superior batch-to-batch consistency.”
S-KiH can closely examine an antibody and identify areas for potential improvements, which are then selected for modification based on how easily different parts of the antibody could pair up. Then, amino acids are added and each variation is tested to find out which ones can more effectively pair up the two different parts of the antibody. The best candidates are selected and tested to make sure any alterations didn’t create unwanted byproducts.
Samsung Biologics’ Expanded CDMO Services
The S-KiH platform is part of a growing suite of services offered by Samsung Biologics, which has quickly become one of the world’s largest CDMOs since its establishment in 2011.
In 2022, Samsung Biologics launched two new drug development platforms, S-DUAL™ and DEVELOPICK™. This expansion in services is part of CEO John Rim’s commitment to diversifying the CDMO’s portfolio, which now also includes investments in areas such as biosimilars, antibody-drug conjugates, and gene therapy.
“Through these new development technologies, we provide early insight and ensure higher yield of molecules, ultimately enabling clients to reach commercialization much more efficiently,” said Rim in a statement following the launch of S-DUAL™ and DEVELOPICK™.
In addition to expanding its service offerings, Samsung Biologics has posted record sales this year, with 1 trillion South Korean won (approximately $766 million) in revenue in Q3 2023 alone. This summer, it commenced full operations at its fourth manufacturing plant, a massive facility that boosts its manufacturing capacity to an industry-leading total of 604,000 liters. Additionally, the CDMO is planning to invest another 7.5 trillion won in building a second Bio Campus. It recently expedited the construction of its fifth plant, which is set to be operational by April 2025. Plant 5 will add an additional capacity of 180,000 liters, helping the company maintain the largest biomanufacturing capacity globally at 784,000 liters.
“We have achieved a remarkable milestone with consolidated sales surpassing 1 trillion won in a single quarter, ultimately demonstrating our commitment to excellence and innovation. Our expanding partnerships with global-leading pharmaceutical companies and a thriving sales backlog reflect the trust our clients place in us and our capabilities,” said Rim in a statement announcing the CDMO’s third-quarter earnings. “Looking ahead, our expansion plans, including the construction of the [antibody-drug conjugates] facility and Plant 5, will meet the increasing market demand and support our clients’ needs for both capacity and business diversification.”