Jan 142015


Scaling from Milligrams to 1-2Kg

see at…………..

2 – 3 March 2015
Sheraton Fisherman’s Wharf Hotel – San Francisco


Fisherman's Wharf, San Francisco

The aim of this professional development course is to provide a good basis to work from when involved in taking development candidates to the first in human trials and with a view on some longer-term requirements. The course content will focus on the necessary early phases of chemical development, as would typically be required to support production of up to about 2kg.

The course will introduce and discuss the following:

  • Requirements in order to move from small (less than 1g) supplies to the first 100g or so for preclinical work
  • Further scaling to 1-2kg 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 with quality requirements
  • 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

Your Course Tutor
Dr John Knight 

John Knight

Register 2 attendees and automatically SAVE 5% plus register 3 people and SAVE 15% on our standard booking fees!


sciupnew logo-master

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

What will you take away from this course…

  • How long it takes 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

View the course brochure

The lectures are interspersed with interactive problem sessions.


Copyright © 2015 Scientific Update LLP, All rights reserved.
Scientific Update LLP, Maycroft Place, Stone Cross, Mayfield, East Sussex TN20 6EW, UK
T: +44 (0)1435 873062 F: +44 (0)1435 872734 E.

missing link

OPRD network


Sorry, the comment form is closed at this time.


Get every new post on this blog delivered to your Inbox.

Join other followers: