The Preclinical Development Support Master Contract (PDSMC) supports all phases of preclinical development, including process and product development, GMP manufacturing and clinical lot production, analytical and formulation, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications.
This contract is with Advanced Bioscience Laboratories (ABL).
Main Areas of Focus
- To support all phases of preclinical development
- Process and product development
- GMP manufacturing and clinical lot production
- Analytical and formulation
- Preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications
Who Can Use This Resource
Innovators/investigators with promising products, candidates, and platforms/technologies including but not limited to cell line development, upstream and downstream process development, characterization and analytics, formulation development and technologies, adjuvant studies, delivery technologies, stability of product components, scalability and manufacturability, and preclinical immunogenicity and testing data emerging from investigator-initiated research studies. Information regarding the current status and capabilities that will allow NIAID to more rapidly and efficiently close development and production gaps leading to Investigational New Drug (IND) submission for Phase I/II clinical testing.