cGMP Manufacturing

IriSys’ formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials for Phase I and Phase II trials.  IriSys cGMP manufacturing team is under the jurisdiction of the Quality Assurance Unit and complies with IriSys’ Standard Operating Procedures and FDA Guidelines.  IriSys provides the following cGMP manufacturing services.

• Scale up from R&D to cGMP manufacturing
• Technology transfer
• Drug Development Process
• Formulation optimization for manufacturing of drug product
• Clinical trial materials manufacturing for Phase I and Phase II
• Release testing
• Certificates of Analysis
• Formal stability studies according to ICH guidelines

IriSys has the capability to manufacture the following dosage forms for Phase I and Phase II clinical trials.

• Capsules, hard gelatin or HPMC liquid-filled
• Capsules, hard gelatin or HPMC, powder-filled
• Capsules, controlled or sustained release
• Tablets, immediate release
• Tablets, controlled or sustained release
• Tablets, enteric coated
• Topical gels, creams, ointments
• Oral liquids
• Over encapsulation