cGMP SERVICES

FORMULATION DEVELOPMENT & DRUG MANUFACTURING SERVICES

IDRI is a non-profit organization performing formulation development and fill & finish services in its state-of-the-art labs and cGMP facilities located in Seattle’s South Lake Union neighborhood.

At IDRI, we provide:

  • Formulation development services with a focus on liquid, emulsion and liposome formulations
  • cGMP drug product manufacturing for preclinical, Phase 1 and 2 clinical studies with a batch capacity of up to 15,000 vials of drug product in compliance with U.S. and EU regulations
  • Stability studies performed in compliance with ICH guidelines

We are rooted in scientific and engineering excellence, and highly value open communication and transparency. Our partner relationships are supported by project managers with in-depth experience and dedication to support the client and project efficiently.

PRODUCT TYPES AND SCOPES

Small molecules or proteins formulated as parenterals in:

  • Liquids
  • Emulsions
  • Liposomes

Pre-clinical to Phase 2 manufacturing for:

  • Pharmacology, toxicology and characterization studies
  • Phase 1 and 2 clinical studies