What is IND-Enablement?
“IND-enabling” refers to the critical steps and milestones required to realize the acceptance and approval of your IND (or similar applications outside of the United States). The objective isn’t application submission— rather, the goal is approval and initiation of clinical trials.
With a diverse set of CMC services, Landmark Bio can help accelerate your program into the clinic, meet regulatory requirements, mitigate program risks, and ensure your path to the clinic is smooth and successful.
Partner with Landmark Bio to design a bespoke CMC work package for your advanced therapy program, leveraging the following comprehensive IND-Enabling Services:
Landmark Bio provides comprehensive non-GMP manufacturing services in support of pre-clinical studies, including material suitable for development characterization, GLP tox studies, etc.
Full spectrum services for upstream and downstream processes to ensure robust, reliable, and reproducible manufacturing of advanced therapies.
Learn more about our PD/AD services
The development and characterization of analytical methods is critical to IND submission and approval. Landmark Bio’s analytical sciences and CMC regulatory teams can develop a tailored work package to facilitate analytical method development and qualification.
Learn more about our PD/AD services
Landmark Bio’s state of the art cGMP facilities, staff, and quality systems are equipped to manufacture diverse advanced therapies suitable for GLP toxicology studies, human clinical studies and even commercial supply.
Landmark Bio recommends the early implementation of a comprehensive CMC Regulatory strategy which serve as a road map for drug development activities, interactions with Health Authorities, IND submission(s), early phase clinical manufacturing, pivotal and late phase clinical manufacturing, process and product characterization, BLA submission, and commercialization. Landmark Bio provides comprehensive CMC Regulatory Services to accelerate your path to the clinic, meet regulatory requirements, mitigate program risks, and ensure your program advancement is smooth and successful.
Learn more about CMC Regulatory Support
To decrease program timelines, cost, and uncertainty, Landmark Bio provides services utilizing proven Viral Vector and CAR-T manufacturing platforms. Platforms Optimized for Scale-up and Transfer (POSTmarkTM) are manufacturing platforms that have been designed to generate non-GMP material using processes that can be readily scaled and transferred to our cGMP facility.