Training Courses

Session 1

Introduction to typical pharmaceutical development activities and timeframes for toxicological studies.

Session 2

Making the first 100g non-GMP batch for GLP toxicological studies; discussion of topics such as setting the specification, the use of chromatography, accessing starting materials, identifying how much development to do.

Session 3

Non-GMP vs GMP preparation. A brief introduction to GMPs and how they impact on the initial chemistry scaling exercise.

Session 4

Physical version and form, spending time on the importance of salt selection, especially in the early phases of development with form/polymorph considerations also being discussed. There will be a brief introduction of polymorphism and which aspects of physical form should ideally be established at the early phase of development.

Session 5

Process safety and raw materials supply issues and how these might impact on the chosen route.

Session 6

Review of the day and questions.

Session 7

Scaling into fixed vessels with discussions about those operations that transfer well and those which typically do not.

Session 8

Technology transfer and a discussion of the issues and suggestions to mitigate against them.

Session 9

A presentation about genotxoic impurities – what are they, what are the suggested control levels, how well do chemists identify them?

Session 10

A presentation about impurities, including their identification, isolation/preparation and control with discussions about setting specifications

Session 11

The final session of the course will review the two days considering the development timeframes and follow-up on any questions.

Case Studies and Problem sessions will also be included throughout the course.

Project managers and those involved in technical outsourcing
Project leaders and bench chemists involved in preparation of material
New starters to the area
Medicinal Chemistry support teams involved in making the first batches for toxicological evaluation

• How long does it take to get from milligrams to 1-2kgs suitable for human clinical trials?
• What are the main hurdles?
• What can be left out and what must be included?
• What are the key project management considerations?

"I think the course was excellent for my current work as a chemist / project manager, because it touches on relevant process scale-up issues without expecting you to become an expert in any one thing."   Pfizer

"Very interesting course. I will recommend it to my colleagues."   Chiesi Farmaceutica SpA

"I'll recommend this course to my process development colleagues. It can help them to identify issues we are fcing at kilogram scale."   Schering-Plough