IRIX Pharmaceuticals, Inc.

IRIX offers:

• Pre-clinical & Discovery Support

A limited focused client-specific service for Discovery and Pre-clinical activities…

• Analogs
• Advanced building blocks
• Reference materials
• Methods development

• Process Research

We apply our wealth of chemistry experience across all therapeutic areas and classes of molecules to…

• Identify and implement quick process improvements in early phases of clinical development to support scale-up without impacting the delivery timelines.
• Discover and demonstrate innovative complete synthesis routes that are:
  • Practical and scalable for late phase development
  • Economical for competitive price advantage
  • Not tied to proprietary technologies
• Create Intellectual Property for our clients and put them on a better foundation for the market.

• Process Development

We use a methodical approach to generate the best process solutions that encompasses all of the critical disciplines…

• GLP Tox and Form Batches

We support the pre-clinical development phase with timely delivery of quality API.

• Clinical Supply

First and foremost is getting your API to meet your clinical timelines. Although effort may be required to handle scale-up issues, we have historically overcome these challenges to meet tight delivery timelines.

• Commercial Production

• Commercial Manufacturing:
  • Batches for qualification, validation and launch
  • Batch isolation of up to two (2) metric tons per batch
• Cryogenic Manufacturing
• High-Pressure Manufacturing
• Filtration, Drying, Milling, Blending
• Cytotoxic and Potent Compound manufacturing
• Controlled Substance Manufacturing

• Stability Studies

• Fully Qualified Chambers
• Qualified (IQ/OQ) Alarm Notification System
• Restricted Access
• Dedicated Stability Manager and Staff

• Regulatory Support

• Robust Quality Systems that continuously evolve and improve to conform to current Good Manufacturing Practices, industry regulations and guidances.
• Commitment to providing quality products and service to meet the client’s needs
• Effective communication and shared responsibility with the client ensures quality at every stage of the project
• Regulatory compliance and development support from pre-clinical to registration and commercialization

• Product Life Cycle Management

We believe in competitive advantage driven by creative process technology not low labor rates. We have demonstrated our ability to create alternative solutions for the life cycle management of client products.