Continuous manufacturing is one of the biggest trends in solid form manufacturing, said Dow’s Amina Faham at CPhI Worldwide’s Pre-Connect Congress on Monday.
However, making solid dose forms requires a large amount of excipients, and not enough is known about the impact of raw materials on flow rate consistency and homogeneity in the continuous process, she said.
“Existing excipients may not be able to address all the needs of the continuous process,” said Faham
“There is a clear need for excipients that are designed for the purpose of the continuous process,” she added.
According to Faham, improved knowledge of raw materials could improve product quality.
“A better understanding and better control of all the key attributes of raw materials – excipients and APIs [active pharmaceutical ingredients] – and how they impact the manufacturability, and quality of the final drug product, is needed,” she said.
The continuous method – said to improve speed and quality in drug production – is gaining support across Europe and the US.
In 2016, the US Food and Drug Administration (FDA) was the first regulator to approve Janssen’s continuous manufacturing method for HIV drug Prezista (darunavir).
Since then, Swissmedic and the European Medicines Agency (EMA) have also cleared Janssen’s move from the traditional ‘batch’ approach to make Prezista.