The acquisition of a Raman/Particle characterisation system will help PSI handle the increasingly challenging tasks that pharma companies are outsourcing to contract research organisations (CRO).
Horiba’s system combines the chemical selectivity of Raman spectroscopy with Clemex Technologies’ particle size and morphology characterisation.
Using this apparatus PSI will be able to discover the precise location of an active pharmaceutical ingredient (API) and identify the size of the particle.
This is of particular use when developing combination products, which PSI works extensively with, according to Robert Lee, vice president, pharmaceutical development at the CRO.
Horiba will provide PSI with guaranteed hardware and software upgrades as they become available and the companies will also collaborate on the system’s application and method development.
This collaboration will allow PSI to have some influence over the final specifications of the product. Andrew Whitley, vice president, sales at Horiba, believes this will ensue the finished system has “the greatest utility and most useful interface possible".
Growth at PSI
The deal with Horiba comes at a time when PSI is adding additional capacity to bring its total facility size to 21,000 sq ft. Current good manufacturing practice (cGMP) compliant warehouse space is being added as well as a purpose-built sampling and weighing area for highly potent materials.
PSI is placing increasing emphasis on highly potent materials, believing that many CROs are unwilling to make the investment needed to safely handle them.
As part of this effort the CRO is cooperating with IES Engineers. IES will be responsible for evaluating incoming materials and placing them into exposure control bands. In doing so PSI believes its highly potent operating standards will mirror big pharma’s.