There has long been demand within the biopharma industry to accelerate the drug development process to meet urgent patient needs. The recent successful and rapid development of COVID-19 vaccines has only escalated this trend, displaying the potential of shorter timelines from early phases of development through Investigational New Drug (IND) Application. However, the key in pursuing these timelines is to maximize efficiency while continuing to stress quality. Recognizing this need, Samsung Biologics, a leading contract development and manufacturing organization (CDMO), has developed the S-CellerateTM platform, which is designed to expedite timelines for cell line development to IND and Biologics License Approval (BLA) by offering clients a quality-driven, seamless drug development approach.
Demand for Faster CDMO Timelines
Following the onset of the COVID-19 pandemic, the pressing need for vaccines foregrounded demand for CDMOs to accelerate time to market.
As James Choi, Samsung Biologics’ Executive Vice President and Chief Information and Marketing Officer, told the European Biopharmaceutical Review, “The COVID-19 pandemic has been one of the greatest challenges globally for biologics manufacturing to date and has been unrelenting since its onset. As a result of the pandemic, CDMOs have seen an increasing demand to deliver drugs to market at an unprecedented speed..”
The U.S. Food and Drug Administration (FDA) reported that 74% of novel drugs approved by the FDA in 2021 used some form of expedited development or review pathway. This included the FDA’s Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and/or Accelerated Approval.
This trend of increasing demand for expedited development and manufacturing is occurring amid continued supply chain stress for CDMOs as the biopharma industry manages the impact of the pandemic.
“The increasing pressure for speed to market is at odds with transfer delays as projects move between sites or companies to perform subsequent processes across the supply chain,” said Choi. “These delays have been worsened by the effects of COVID-19. The ability to obviate these delays will continue to be a pivotal criterion in selecting a manufacturing partner.”
Samsung Biologics’ S-CellerateTM platform is a solution to this problem, offering Samsung Biologic’s partners a faster end-to-end drug development solution that can avoid transfer delays and other supply chain issues to meet expedited timelines with quality production.
What is S-CellerateTM and How Does it Work?
S-CellerateTM is a drug development service platform designed to deliver optimized quality while expediting the development and commercialization of monoclonal antibodies.
Using the process platform, Samsung Biologics’ clients have been able to reach IND filings in as few as nine months. These expedited timelines are accomplished by providing clients with Samsung Biologics’ complete spectrum of services, from process characterization and validation to BLA submission, while maintaining the highest operational quality standards.
Samsung Biologics engages in a thorough assessment of a client’s molecule. This process involves three independent feasibility studies and a toxicology batch that can be conducted in-house to speed up the collection of data and client feedback.
Process parameters are developed based on statistically significant, cumulative design of experiments (DoE)-based historical data on purity and high productivity in previous molecules. The platform process relies on proven raw data and DoE to save time and offer clients a high probability of success.
Finally, S-CellerateTM utilizes Samsung Biologics’ library of platform raw materials, resins, consumables, and other materials. This avoids potential delays caused by supply chain disruptions while ensuring the minimization of risk.
The result is a drug development process that optimizes quality while reducing time to market, delivering on Samsung Biologics’ promise of a scalable, repeatable, robust process with productivity, yields, and product quality.
A key motivation in developing the S-CellerateTM platform was to provide end-to-end services that produce a quality product and guide it through successful regulatory filing while maintaining the capabilities to respond to future product needs and fluctuating demand. Samsung Biologics’ ability to provide these services under one roof in a facility compliant with good manufacturing practices (GMP) sets it apart from other CDMOs.
“By leveraging this proprietary drug development platform, our teams of experts will jointly provide seamless one-stop services to our clients, offering enhanced solutions that can help reduce both cost and time, catering to their specific needs,” said John Rim, CEO of Samsung Biologics, when S-CellerateTM was introduced at the 2021 BioProcess International Conference (BPI 2021).
Accelerating the Future of Drug Development
While COVID-19 brought the need for accelerated biopharmaceutical development to the world’s attention, shortening timelines has long been — and will continue to be — a goal in the biopharma industry. For CDMOs, effective strategies to expedite drug development establish both the capability to adjust to unexpected shifts in manufacturing demand such as those caused by COVID-19, and to routinely provide clients with the benefits of a faster IND timeline.
When selecting a manufacturing partner, organizations looking to be first to market for a given drug will look for CDMOs that can provide faster timelines without sacrificing quality. In developing the S-CellerateTM platform, Samsung Biologics is meeting this need. The future of drug development solutions will rely on innovations that combine speed and quality, and S-CellerateTM is a leading example of this kind of solution.
