There have been a number of papers on the subject of how to specify regulatory starting materials, with a bench marking exercise carried out by the IQ Consortium1.  Now a sub-group has published a risk assessment tool to evaluate potential regulatory starting materials2, particularly in early development. For any proposed RSM a score is built

Flow chemistry is big news at the moment, but one of the issues from a scale up perspective has been carrying out some of the process hazard analysis, and in particular reaction calorimetry.  If reactants are unstable either thermally or chemically is it possible to get meaningful results from a conventional reaction calorimeter?  A recent

Photochemistry has to me always seemed to be an area whose potential for industrial manufacture has never been realized. I may be biased (I did my PhD on photochemistry from 1967-1970) but I feel the tremendous synthetic potential of photoreactions has not been exploited enough.  One of the reasons is that scale up of batch

Considering the environmental footprint of a typical pharmaceutical / agrochemical process, 60-80% arises from the use of solvents.  Good solvent selection and use – can be the biggest positive hit on improving the sustainability of a process. The timely identification of an optimum chemical route can save you time and money.  An efficient route, selected

This excellent paper from BMS describes a method for predicting the process mass intensity (PMI) for a given chemical step or for a whole synthesis, and thus provides a new way to compare synthetic routes even at the design stage. At the heart of this approach is an internal database of PMI scores for 15

Permissible limits for impurities during clinical development has always been a grey area. Existing guidelines, specifically ICH Q3A only formally apply to marketed products. How factors such as duration of clinical trials have never been effectively addressed.

Whereas process parameter risk quantification is conducted using mathematical calculations (Monte Carlo simulations) based on a process model, risk analysis is a semi-subjective methodology, of value for both early, as well as for late process development work. Herein we will focus on early process development, when little experimental information is available. In spite of its

In the past, the particle size of finished APIs was mostly controlled by processes such as milling and micronization, but this often creates fines and can lead to formulation issues for some compounds. More recently companies are trying to control the particle size of the product as part of the crystallisation process (not forgetting that

Industrial homogeneous catalytic processes are dominated by the use of expensive precious metals and rely on very efficient catalytic cycles for their cost effectiveness. Many of the processes carried out with precious metals are also achieved by iron catalysis, but often other processes compete and these chemistries have not been so widely used in industry,

Meanwhile in another presentation from the 4th Winter Process Conference this time from Alexandra Parker of AstraZeneca discussed the development of the manufacturing route to make Lesinurad (Zurampic) a selective uric acid reabsorption inhibitor approved for treatment of hyperuricemia associated with gout in combination with a xanthine oxidase inhibitor (XOI) in patients unable to achieve