Customized CMC Solutions

Samsung Biologics offers a comprehensive suite of Chemistry, Manufacturing, and Controls (CMC) solutions designed to address the specific needs of your pre-clinical and early clinical development programs. These customizable packages prioritize regulatory compliance, quality, and efficiency:

• Simplified IND Package: This streamlined approach prioritizes an expedited timeline for Phase 1 Investigational New Drug (IND) applications, utilizing the company's established platform technologies.
• Comprehensive IND Package: This option offers a multifaceted approach that mitigates risk through a thorough assessment and generation of a robust data package encompassing extended studies.
• Enhanced CMC Package: This targeted option focuses on quality optimization by offering the replacement of cell lines, processes, or formulations to enhance key features of your molecule.

By leveraging Samsung Biologics' diverse portfolio and proprietary platforms, these customizable CMC solutions can address unique developmental challenges and propel your molecules towards IND filing and beyond, ensuring a smooth and efficient transition into the next stage of development.