Archived: Chemical Development & Scale-Up in the Fine Chemical & Pharmaceutical Industries

Date: 11 October - 13 October 2017

Location: Lisbon, Portugal

Tutors: Dr Will Watson, Dr John Knight

Chemical process development is generally not taught as part of degree courses in higher education; the conversion of a synthetic route used for making milligram or gram quantities of a chemical into a process for manufacturing multi-kilogram and tonne quantities is typically learnt “on the job” by chemists in industry.

For many years, little chemical development work was published in the literature, until the establishment of the Organic Process R & D journal by Dr Trevor Laird (Founder of Scientific Update). Even now, “tricks of the trade” are handed down within individual company organisations, and it can be difficult to gain an awareness of what is involved in chemical development, and of the skills and techniques required to efficiently scale up chemical processes.

This three-day course, written and presented by highly experienced process chemists from the pharmaceutical and fine chemical industry, provides a comprehensive overview of this fascinating and important element of the chemical industry. A logical investigative approach to all aspects of chemical development is described, with an abundance of case studies from literature, conferences and private communications. The multi-disciplinary nature of chemical development is emphasised, from the initial interaction with laboratory research scientists to the vital partnership with chemical engineers in the pilot plant and in the production environment. The lectures are interspersed with interactive problem sessions, enabling participants to share in the problem solving and troubleshooting typically experienced during chemical development.

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Course Outline

Introduction

  • The purpose of chemical development

Synthetic Route Discovery

  • Route design
  • Selecting the best route for scale-up
  • Choice of raw materials, reagents etc
  • Costing of Chemical Processes
  • Raw materials
  • Overheads
  • Context

The Investigative Approach to Chemical Development

  • Optimising Chemical Reactions
  • Making processes robust
  • Minimising scale-up difficulties

Solvent Effects

  • Often overlooked
  • Key to making a modest process a great process

Statistical Methods of Optimisation

  • Vital, but under-utilised
  • Design of Experiments
  • Simplex
  • Factorial design

Analytical Issues

  • In Process Control
  • Quality Control and Specification Setting
  • Regulatory Guidelines
  • GMP, Validation
  • Use of analysis to aid process optimisation

Work Up

  • Product isolation

Planning for Scale-Up

  • Key points to consider

Appreciation of Chemical Engineering Principles

  • Mass Transfer
  • Mixing
  • Heat Transfer
  • Kinetics

Crystallisation and Polymorphism

  • Particle size control
  • Polymorph control
  • Methods of analysis
  • Crystallisation of chiral compounds

New and Emerging Technologies in Process R&D

  • Microwave chemistry
  • Continuous flow chemistry
  • Process intensification

Thermal Hazard Testing and Runaway Reactions

  • Essential process safety considerations
  • Equipment and screening approaches

Effluent Minimisation and Control

  • Environmental considerations
  • Cost considerations
  • Green chemistry

Benefits of Attending

AT THE END OF THE COURSE PARTICIPANTS WILL HAVE GAINED:

  • A logical investigative approach to chemical development and optimisation.
  • An insight into the factors involved in development and scale-up.
  • An appreciation of chemical engineering concepts, particularly mixing, heat transfer and process control.
  • A preliminary knowledge of statistical methods of optimisation.
  • Improved ability to decide which parts of the chemical process to examine in detail
  • Ideas for efficient resource allocation
  • Improved troubleshooting and problem solving ability

Who Should Attend

  • Young Chemists who have just started work in industry as development chemists
  • Organic Chemists/Medicinal Chemists in Research and Development who would like to gain an appreciation of development and scale up and who are perhaps contemplating moving into chemical development.
  • Development and Production Chemists in industry who would like to improve their efficiency and gain an insight into alternative approaches to chemical development.
  • Chemical Engineers who wish to understand a chemist’s approach to chemical development of batch processes. (Engineers would, however, need a good grounding in organic chemistry)
  • Students who are about to enter the industry and can obtain company sponsorship.
  • Experienced Chemists looking to refresh and/or augment their knowledge of chemical development
  • Analytical Chemists who wish to gain a broader appreciation of process chemistry
  • Managers who might benefit from a comprehensive and up to date overview of chemical development

Chemical Development Feedback

What's Included

The course fee includes:

  • comprehensive course manual
  • coffee/tea refreshments breaks throughout each day
  • buffet lunch each day
  • course dinner on the first evening
  • course certificate

Testimonials

Takeda Pharmaceuticals

The course is interesting and informative, overall it’s been an excellent experience and I would recommend it to anyone who is new to process chemistry. It was a pleasure chatting with Will and John. I hope to cross paths with them again in the future!

UCB Celltech

A very nice course! Intensive, informative and a whole bucket of fun!

Beni-Suef University

The course is well organised, deep and very informative. I highly recommend it.