API Process Chemistry & Route Selection
A two-day practitioner-led program enabling pharma and CDMO teams to evaluate API synthesis routes through process chemistry, cost, impurity control, safety, sustainability and commercial manufacturing considerations.
Course Summary
Selecting an API synthesis route influences development timelines, manufacturing costs, impurity control, safety and the quality of data available for regulatory filings. A route that performs well at laboratory scale may introduce significant challenges during pilot or commercial manufacturing.
This two-day program helps pharmaceutical and CDMO professionals evaluate synthetic routes beyond laboratory feasibility. Participants connect chemistry decisions with raw-material availability, process operability, environmental impact, analytical requirements and manufacturing readiness.
The program combines technical concepts with practical business considerations relevant to internal development projects and client-sponsored CDMO engagements. Through route-comparison exercises and scale-up failure discussions, participants learn to justify recommendations, communicate uncertainties and identify the evidence needed before progressing a route.
Who Should Attend
- API R&D Scientists and Process Chemists
- Process Development Scientists
- Pharmaceutical Development Professionals
- Technology Transfer Engineers and Leads
- Technical Project Managers
- Analytical R&D Professionals supporting process development
- Manufacturing and Process Engineering Professionals
- Emerging R&D Managers
- CDMO Technical Business Development and Client-Facing Professionals
Recommended baseline: Working knowledge of organic chemistry and pharmaceutical development. The program is particularly suited to junior-to-mid-level technical professionals progressing towards cross-functional responsibilities.
Business Outcomes
Participants will be able to:
- Evaluate candidate routes using a structured selection framework.
- Identify development risks before committing resources to scale-up.
- Connect process chemistry decisions with cost, quality and delivery requirements.
- Improve coordination between R&D, analytical, manufacturing and regulatory teams.
- Present clearer technical recommendations to management and CDMO clients.
- Define further experiments and specialist reviews required for route progression.
Course Content
Day 1: API Development, Route Scouting & Selection
Day 2: IP Review, Green Chemistry, Safety & Route Recommendation
Meet Your Instructor
Dr. Praveen Cherukupalli is Research and development expert with 26 years of experience in the Life Sciences, industry with exposure in the India region. Currently working as Head, API-Research & Development at Shilpa Pharma, & previously worked as Senior Vice President & Head, API - R&D at Innovare Labs. Skilled into Business development, risk management and process management. Worked across Drugs/ Medicines, Pharmaceuticals, Life Sciences, industry.
₹2,00,000
This course includes:
- Lessons 8
- Topics 102
- Duration 2 Day
- Quizzes 0
- Language English
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