Most recently, the contract development and manufacturing (CDMO) division of Servier announced a $7.5m investment to expand its preparative chromatography platform at its Bolbec site in Normandy, France.
According to the CDMO, the investment covers new technology, including continuous chromatography with simulated moving bed (SMB) and supercritical fluid chromatography (SFC) with solvent recycling of up to 90% to lower environmental impact and an approximate 50% increase in productivity.
The Bolbec site is certified to handle highly potent compounds to occupational exposure band five (OEB 5) and a fully United States Food and Drug Administration (FDA) current good manufacturing practice (cGMP) site for human pharmaceuticals.
The investment will enable the chemical purification of 50kg (kilograms) per day and the chiral separation of 10kg per day to support clinical trials and market supply following drug approval, the company said.
“With this new investment – that will be ready by July 2018 – we should be able to increase the productivity, and also, the platform will have a big impact on environment, because we’ll recycle most of the solvent that will be used for the purification,” Gwenaël Servant, Ph.D., managing director, Servier CDMO told Outsourcing-Pharma.com.
Additionally, Servant said the platform, while suitable for clinical phases, can also be used for high-value production molecules, depending on the volume.
“[The platform] is something that you can consider for high-value API,” he explained. Depending on workload, the platform has five to ten people working on it and can run 24/7.
“The demand from the industry is quite clear,” added Servant, “Now, everybody wants to go very fast to the market.”
“With this investment, we hope that we can help our partners to really speed up their process and even to think about this technology for really important batches.”
Investing in its network
In addition to the investment at the Bolbec site in Normandy, Servier also has a special project underway that will double the capacity of its Chinese facility, Servant said. The new unit at Servier Tianjin Pharmaceutical Co. Ltd is currently under construction and is expected to be fully operational by 2020.
Servant said the company has also invested approximately €50m ($58m) in France to support biologics.
“In parallel, at our Irish sites we are investing to be ready in one year from now – October 2018 – for high potent drug products,” up to OEB 5, he added.
Additionally, the company has a program in place at its headquarters in France to manage its serialization progress across all its sites.
“It’s going to be tough for a lot of companies to comply with all the regulations because all the regulation isn’t the same,” said Servant. “You have to be ready.”
The US Food and Drug Administration (FDA) extended the serialization deadline following concerns the industry was not ready. In the draft guidance, the FDA explained enforcement of the Drug Supply Chain Security Act (DSCSA) will be extended until November 2018 – adding an additional year to the original deadline.
To meet the new deadline, Servant said Servier is investing around €20m this year and next to “be able to manage all these new requirements from a regulatory point of view.”
“Servier is constantly investing in its network to develop new capacities, new possibilities, and Servier CDMO can offer those novelties to third parties,” he added.