Custom pharma solutions

In 2010, Veranova was selected by a customer because of our controlled substance expertise and manufacturing knowledge of a key intermediate for their API. We developed a 2nd generation process, utilising our solid form sciences expertise to solve a significant challenge with the final form of the drug substance. Over the years, we’ve continued to work closely with this customer’s development team to continue to improve the efficiency of the process, meet clinical material and timeline needs and scale the process up to 8,000 L reactor scale.

Veranova continues to provide additional expertise to support regulatory filing as well as perform some of the critical post-validation process research activities. Veranova validated the process in 2018 and were contracted to produce commercial launch API in 2019.

One customer required help to accelerate the approval of a drug for an unmet medical need. We were able to leverage our expert knowledge of complex multi- step chemistry, challenging purification, chromatography modelling, identification and characterisation of impurities and regulatory filings to help accelerate their drug approval.

We were then able to scale-up rapidly, including the creation of a new multi million dollar manufacturing site. Six different Veranova sites contributed to the success of enabling the product.