Solid Orals Development
Mr. Michailaros provides over 21 years of drug product expertise with both oral and solid processes, and product development and manufacturing. He specializes in difficult technical formulation and manufacturing challenges and products with unique requirements, including controlled release, zero-order release, abuse deterrence, pediatric formulations, oral disintegration. In addition, he has developed, and optimized products including controlled release tablets, abuse deterred capsules, pediatric formulations, solid and liquid filled capsules, suspensions, inhaled products, and transdermals.
Mr. Michailaros has helped author regulatory submissions in the EU as well as in the US and has worked extensively with international vendors. He has extensive experience in project management, scale-up, tech transfer and validation, lean manufacturing, six sigma/process excellence, design of experiments (DOE), chemistry manufacturing and controls (CMC) regulatory submission authoring, capital projects and third-party manufacturing management.
- Led Product Launch teams for time sensitive milestones,
- Authored development protocols, reports, and CMC sections for regulatory filings,
- Experience in regulatory CMC strategy for drug development,
- Production troubleshooting of pharmaceutical oral solid dosage forms.
Before joining DSI, Mr. Michailaros was Senior Engineer, Validation and Commercial Technical Services at Teva Pharmaceuticals as well as Johnson & Johnson. He has served DSI clients for over ten years. He earned a chemical engineering degree from Lehigh University and a mini MBA in Management Essentials from Rutgers University.
- Formulation Development
- Process Validation
- CMO Transfer
- Due Diligence
- Person in Plant
- CMO Selection
- GAP Analysis
- Project Management
- Process Scale-up