Course Catalog

Scaling from Milligrams to 1-2kg: Making the first GMP Batch

The aim of the course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements.  The course content will therefore focus on the necessary early phases of chemical development as would typically be required to support production of up to about 2kg using laboratory-based 20L glassware and pilot plant equipment.  The course will introduce and discuss the following:
•    Requirements in order to move from small (<1g) supplies to the first 100g or so for preclinical work
•    Further scaling to 1-2kgs non-cGMP
•    Requirements to make material for use in clinical trial – an introduction to cGMP coupled with the scaling issues
•    An overview of the requirements to move processes to fixed vessels, assuming cGMP is required – what operations can readily be transferred and those that should ideally be developed out
•    The phases of development and indicative timelines
•    The importance of physical form selection, understanding and control
•    Impurities and their control, with specific discussion on genotoxic impurities and developing the specification for the API as it moves from preclinical batch preparation to cGMP batches for clinical trials

During the course, the lessons and the key learning opportunities are considered to be:
•    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?

Course Details

Key Topics

During the course, the lessons and the key learning opportunities are considered to be:
•    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?

Information

The aim of the course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements.  The course content will therefore focus on the necessary early phases of chemical development as would typically be required to support production of up to about 2kg using laboratory-based 20L glassware and pilot plant equipment.

Who Should Attend

•    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

Agenda

The course will be given over a two-day period with the following content and structure:

Day One:

The course begins with registration at 8.45am on Day 1 and finishes at approximately 4.30pm on Day 2.

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.

Day Two:

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 time-frames and follow-up on any questions.

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the day of the course.

Course runs from 8:30 a.m. to 5:00 p.m.

Register Via Mail

Venue

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
  Member Non-Member
Advanced $1,695 $1,895
Standard $1,895 $2,095

About the Instructor