MANUFACTURING

IDRI partners for small-scale formulation and aseptic filling of liquid drug products for preclinical and Phase 1 & 2 clinical studies. We perform cGMP manufacturing in our state-of-the-art clean rooms in compliance with U.S. and EU regulations.

Filling

The filling is done with an automated filling, stoppering and capping machine or in a semi-automatic operation. The semi-automatic option is typically used for the manufacture of small batches.

Drug product sterilization can be done aseptically (filtration through 0.22 µm filter) or terminally (autoclaving). Our services are individualized and performed with flexibility per our customers’ needs.GMPvials

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

The product scopes include large and small molecules in liquid formulations, vaccines (non-viral) and adjuvants in liquid forms, emulsions and liposomes. Complex adjuvant formulations based on emulsions and liposomes have been part of IDRI’s core expertise for more than 10 years.

Manufactured drug product lots are release and stability tested by our Quality Control team. Stability studies are performed per ICH guidelines. Analytical development and pre-formulation / formulation development services are executed by IDRI’s highly skilled R&D and Quality Control staff.

Communication is very important in the relationship between our clients and the IDRI team, and each project is assigned a project manager to facilitate real-time information exchange. We welcome and encourage “person-in-plant” attention during cGMP operations. The IDRI cGMP suite is designed for easy monitoring, and activities in the clean rooms can readily be observed in detail without any interference.

The following lists illustrate the breadth of IDRI’s capabilities.

  • Formulation development
    • Analytical development
    • Method verification
    • Method qualification
  • Manufacturing
    • Engineering run for pre-clinical purposes
    • cGMP run for Phase 1 and 2 clinical studies
    • Labeling of small lots (<2,000 vials)
  • Release testing
  • Stability study
  • Project management
  • Vial Sizes: 2 mL – 100 mL
  • Fill volume: 0.3 – 100 mL
  • Capacity: Up to 15,000 vials/batch
  • Filling: Semi-automated or fully-automated
  • Nitrogen purge
  • High Shear Mixer
  • Microfluidizer
    • Pilot:110EH (bulk batches of e.g. 0.1-1L)
    • Full Scale: M7250 (bulk batches of eg. > 1L-100L)
  • Chase-Logeman FSAS-2205
  • Flexicon Peristaltic Filling System