HIV Drug Formulation Development and Manufacturing Services

This service program supports the development and manufacture, of a wide variety of pharmaceutical dosage formulations, including tablets, capsules, semi-solid preparations, injectibles, and sustained-release products. If requested, manufacturing can be done under GMP.

Main Areas of Focus

  • To fill specific gaps in an investigator’s drug development plan as they advance their product towards clinical investigation
  • To help investigators obtain data to get additional funding
  • To help with prospective partnerships
  • To help getting regulatory permission to continue

Support Services

  • Characterization of physical and chemical properties of bulk drug substances targeted for formulation development
  • Formulation development to enhance drug solubility, improve bioavailability, enhance drug stability, deliver to target tissues, and treat specific patient populations
  • Stability and release properties of formulations in analytical and in vitro assays
  • Long-term stability studies of manufactured formulations
  • Formulations can be manufactured, packaged, labeled, and shipped under GMP guidelines. 

Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf.

Who Can Use This Resource

  • Product must be defined and of known chemical structure
  • Investigator must have preliminary data to support the continued development of product

How To Get Started