A unique combination of talented scientists with broad chemistry and pharmaceutical production experience, state-of-the-art facilities, and a broad spectrum of technical capabilities sets IRIX ahead of the pack.

  • Staff

  • Experienced scientific staff with an average of greater than 15 years of industry experience
  • Numerous patents
  • Detailed working experience in taking new drugs through launch (Xeloda, Calcitriol, Omniflox, Hivid, etc)

  • Process R&D

Sharp Solutions®

  • The implementation of creative IP to enhance client prouct competitiveness and circumvent roadblocks.
  • Trusted resource for API process development and manufacturing.
  • Unparalleled demonstration of scientific creativity and process hands-on experience highlighted by 31 process patents filed on behalf of our clients.

  • Manufacturing

We routinely produce APIs for use as early as a GLP Tox and Form batch, cGMP for clinical deliveries, validation, launch, and commercial manufacturing. Special capabilities include cryogenic and high-pressure up to 2000-liter scale.

Click for a complete overview of our facilities.

  • Clinical Supply:
    • Quickly identify and resolve scale-up challenges
    • Provide comprehensive regulatory documentation
    • Identify and utilize a process that is robust and reproducible
  • Commercial Manufacturing:
    • Demonstration of Proven Acceptable Ranges (PARs)
    • Identification of Critical Processing Parameters (CPPs)
    • Batches for qualification, validation and launch
    • Use of robust, reproducible, and cost-efficient processes
    • Batch isolation of up to two (2) metric tons per batch
    • Cryogenic, high-pressure and high-potency all at large-scale
  • Cryogenic Manufacturing:
    • Low-temperature capabilities down to -85°C up to 2000 liters
  • High-Pressure Manufacturing
    • IRIX has the extraordinary capability of high-pressure processing, including hydrogenation, up to 1000psi at 2000-liter scale

  • Technology

  • Chemical and Biochemical
  • Chiral
  • Separation
  • Solid-state Characterizing

  • Special Technologies
  • High-Potency:Whether it be your cytotoxic oncology therapeutic or a highly potent compound, IRIX has the facility to help. (more...)
  • ß-Lactam:One of the unique capabilities IRIX has is the ability to produce ß-lactam antibiotics at small-scale. (more...)
  • Controlled Substances:Both our Florence and Greenville sites are licensed by the DEA to produce controlled substances. (more...)

  • Expertise

Demonstrated Unique Expertise with the Following Classes of Compounds:

  • Prostaglandins
  • Quinolones
  • Vitamin D metabolites
  • Nucleosides
  • ß-lactams
  
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