cGMP Manufacturing

IriSys cGMP Manufacturing Services

IriSys’ experienced formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials and commercial pharmaceutical products. The cGMP manufacturing team complies with IriSys’ rigorous Standard Operating Procedures and FDA Guidelines.

Commercial manufacturing requires a higher level of knowledge, performance, and regulatory scrutiny than production of clinical trial materials. IriSys has successfully met the requirements for audits conducted by regulatory authorities including recent FDA and California Food & Drug Board inspections.

IriSys provides the following cGMP manufacturing services:

• Scale up from R&D to cGMP manufacturing
• Technology transfer
Drug Development Process
• Formulation optimization
• Clinical trial materials manufacturing
• Pharmaceutical products manufacturing
• Release testing
• Certificates of Analysis
• Formal stability studies according to ICH guidelines
• Commercial product manufacturing

IriSys has the capability to manufacture the following dosage forms for clinical trials and commercial products.

• Capsules, hard gelatin or HPMC (hydroxypropyl methyl cellulose), 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