Develop processes fit for purpose without evaporations or residues
| 29 January 2010
Having had over a decade working within the CRO business I have routinely come across the need to rapidly develop and scale up early phase development targets. This is the fairly standard model, especially for small pharma and biotechs using contract development and scale-up facilities working against tight timeliens with imited budgets. But even against that back-drop, I would aim to devsie and define processes with a longer-term view in mind.
To some extent, I am starting to question this approach.
Last year I was involved in auditing an Indian manufacturing facility wherein they make several tonnes of an API per annum using about an eight-stage synthetic route. I was intrigued to note that in this established manufacturing process which clearly worked well and had been operating 7d/24h for some time, they had evaporations to dryness or residues at at elast 3 different stages. This approach to manufacture shows a tremendous pragmatism which in my experience is quite at odds with what would be done in 'western' manufacturing plants where we would work on solvent exchange processes or ideally use a single solvent, perhaps compromising yield for operational ease. I appreciate there are risks associated with such practices, but perhaps when developing processes we should not be trapped by the dogma of our own experiences and be sure to keep an open mind.
The above difference also highlighted for me the care we need to take when working with CROs for development work; one person's developed process may well be another's laboratory method. I therefore would encourage careful and precise discussion during the proposal review stage to ensure that what is planned to be carried out will not only meet the supply needs but also match the requirements of the project and expectations of the paying client.
Personally, I will continue to try to develop processes fit for purpose without evaporations or residues, but will also be mindful that at times it is an option!
Technical consultants
| 15 December 2008
What do they bring to the table?
We are all familiar with the expression ‘those that can do, those that can’t consult’ but is this really fair? In this article I plan to explore what it is that consultants bring, both positive and negative, when they’re engaged, based on my own experiences of using consultants, working within a CRO where my clients used consultants to challenge my proposals and most latterly, working as a consultant to support chemical development programmes for my clients.
