An open discussion of experiences would be helpful to many involved in the development process to be aware of what has worked and what has not for those who have experience with expedited development programs.Dan Torok Director, API Process Development DS In Pharmatics A lot of chemists have moved away from asymmetric hydrogenation and classical resolution to favour enzymes. Davies LLC Let's go with the givens of adding fluorine to and API, i.e. Handling issues to consider with the choice of the timing.In my view this is not always the best route to take and we should be looking for fit for purpose technology for early phase clinical projects and the best technology for commercial applications. Senior Vice President, Global Business Development Chiral Quest Ian Davies, Ph. different metabolism than the non-fluorinated analog, more lipophilic molecule with fluorine, longer acting API results. Means of introducing the fluorine such as actual distinct fluorination of the primary molecule or via a key part of the molecule added later.
It also provides for the use of hazardous chemicals and extreme reaction conditions.
Quality by Design (Qb D) is built into the system as there is a high level of process control and reproducibility.
Just how secure is our supply chain and how can we make it ..secure?
Stuart Silverman Business Development Albemarle The FDA now allows for several forms of expedited pathways for serious conditions.
In many instances this forces Phase II to become the defacto Phase III.
This often requires that the process and method employed during Phase II manufacture to be viable for validation or at the least validation readiness within a very short time frame.
Continuous processing using small-scale equipment results in improved energy and material use as well as increased capacity. Business Management Director, API Patheon Solid State science is a corner stone of drug development that could significantly impact the vital physical properties such as solubility and dissolution rate as well as API and drug product processability.
What if you didn't have to "scale up" but could "number up"? Furthermore, it could extend the lifetime of the drug through IP protection. Modern pharma research rarely uses the go-it-alone approach.
For instance, a catalyst was developed or a customer a few years ago; it was eventually scaled to 750kg for the commercial production of Januvia (their diabetes drug). Leading Scientist Catalysis Solvias AG Continuous flow manufacturing has advantages over traditional batch production.