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Case Study No. 2

Shaving Time Off the Product-to-Market Cycle

Getting a new pharmaceutical product registered and on the market is a lengthy and expensive process. If weeks or months can be shaved off the time-to-market cycle, it has major profit implications. Which is why this major Australian pharmaceutical company first turned to ChemicalAnalysis for expert help.

The product was a hormone, recently out of patent and being developed in a new tablet form. Re-registration was required, and ChemicalAnalysis was able to offer them the unique combination of a GMP environment and access to instrumentation such as LC-MS and NMR usually only found in university laboratories.

Our task was to look at impurities that formed in the active material over time, particularly at elevated temperatures. Other companies had already spent much time and effort researching the problem, but with little result.

For ChemicalAnalysis, it was a different matter. With the right instrumentation at our disposal and extensive experience in such high-end problem solving, we were able to make swift progress in identifying the classes of compounds to which the impurities belonged and the possible mechanisms through which they were forming.

As a pharmaceutical company, the fact that ChemicalAnalysis has its own TGA licence is an important consideration for us. They also understand the importance of protecting and maintaining intellectual property, which is vital in our market. Their contribution has had a key impact on our drug screening and discovery program and enabled us to reduce time-to-market considerably on a number of occasions.

ChemicalAnalysis continues to perform regular work for this particular pharmaceutical company, solving contamination problems, reducing manufacturing downtime and providing vital input into new method development and validation, crucial issues they sometimes do not have the time, expertise or resources to carry out themselves.

As experts in their area, the pharmaceutical company simply tell us what they want to achieve. As experts in ours, we are able to draw upon our understanding of their needs and products, as well as our wider experience of other industries, to come up with the answers they require.