Available as an in-house course

Active Pharmaceutical Ingredients

- Development, Supply and Commercial Manufacture

Course Overview

This 2 day course is designed to give an overview of the development of chemical processes for the supply of active pharmaceutical ingredients for human consumption both in clinical trials and commercial manufacture. Each step from the selection of a new candidate from Discovery into Development through to commercial launch is covered. Particular emphasis is placed on the differences between a laboratory procedure and an economically viable manufacturing process.

These include:

                 *Process economics.
                 *Process safety.
                 *Environment protection.
                 *Quality of product.
                 *Specialised facilities for highly potent substances.

Who will benefit from the course?
Chemical and Process Engineering Scientists involved in the design, development and technical support of chemical manufacturing processes in the pharmaceutical industry. Chemical Analysts providing process analytical support to laboratory, pilot plant and full scale manufacturing operations. Formulation Scientists and Health, Safety and Environment professionals seeking a more detailed knowledge of the operational aspects of process chemistry. Those involved in technology transfer from laboratory to pilot plant to full scale plant and from manufacturing plant to other manufacturing locations.

Course Speaker
Dr Ron Scott is a Director of Chemical Services at Pharmaceutical Development Services and has experience in all aspects of the development of chemical processes and manufacture of active pharmaceutical ingredients. He has a First Class honours B. Sc. in Chemistry and a Ph. D. in Synthetic Organic Chemistry and is a Fellow of The Royal Society of Chemistry.
During a 25 year career he has worked in leading contract manufacture and contract R&D organisations including Oxford Asymmetry and Almac Sciences where he held senior management positions in technical operations up to Vice President level.
He has had responsibilities for New Product Development, Process R&D, Process Safety, Quality Control, Quality Assurance, Production and Environmental Compliance.
He specialises in the design and optimisation of robust and economical chemical processes for the supply of new chemical entities for clinical development and subsequent commercial manufacture. A particular niche area of expertise is the design and safe use of facilities for handling highly potent active pharmaceutical ingredients, typically for oncology applications.

Programme

Medicinal Chemistry

         • Molecular Screening
         • Hit Identification
         • Hit to Lead Compound Selection
Pre-Clinical Development
    • Lead Compound Route Selection
         • Viability of Process for Future Material Supply
         • Availability of Raw Materials

First Material Supplies to Pharmaceutical Development
         • Outsourcing Versus In-House manufacture
         • 500g non-GMP
         • 5kg GMP
         • 50kg GMP
    • Moving Chemical Development off Project Critical Path

Highly Potent Active Pharmaceutical Ingredients
         • Special Classifications of Active Pharmaceutical Ingredients
         • Dedicated Handling Facilities
         • Occupational Hygiene
         • Medical Surveillance

Clinical Supply
   • Phases I, II and III
   • Chemical Process Development

• Yields
• Quality
• Process Economics
• Process Safety
• Environmental Compliance

• Process Analytical Technology
• Process Transfer from Laboratory to Pilot Plant
• Process and Analytical Documentation
       • Product Polymorphs
       • Product Stability
       • Validation of Plant, Process and Analytical Techniques
       • Chemical Manufacturing and Control Dossier
Pre-Approval Inspection

       • ICH Q7A
       • Requirement for Marketing Approval of a New Drug Substance
       • Rigorous Inspection of Good Manufacturing Practice
       • Reporting of Violations
Commercial Manufacture

• Site Selection for Process
• Low Cost Economies
• Protection of Intellectual Property
• Drug Substance Economic Life Cycle