With drug companies looking for ways to get to market faster and start realizing revenue streams sooner, two European contract manufacturers are touting single-use, disposable technology that they claim will help customers do just that.
Merck Millipore, the contract development and manufacturing division of Merck KGaA, has opened a new plant in Martillac, France, using single-use, disposable technology, even as competitor Boehringer Ingelheim says it is putting the technology throughout its manufacturing network to speed processes and flexibility.
According to Manufacturing Chemist, Merck's new plant has 50 liter to 1,250 liter scale capabilities for production of mammalian proteins for pre-clinical to Phase II production. When processes are reading for Phase III and commercial production, Merck says the processes can be transferred to any location and instituted at any scale. It says its technology makes it possible to move from clone selection to a GMP product in 12 months.
Christophe Couturier, vice president of services, tells Outsourcing-Pharma that the plant will have 95 employees and be able to run 10 to 12 projects in parallel. A distinction, he says, is that customers "will own the process and be able to transfer manufacturing to a location of their choice. This 'open source' platform does not lock clients into a proprietary process but rather it gives them flexible options for late-phase and production-scale manufacturing."
Boehringer Ingelheim is selling the flexibility of its system. The Boehringer system handles both upstream production units such as bioreactors and downstream processing units such as sampling, filtration and purification systems, as well as all the connecting components, InPharm points out.
BI claims its system allows development to move from gene to drug product in 16 months. A spokesperson for Boehringer Ingelheim says in an email to FiercePharmaManufacturing that of the company's biopharmaceutical development and manufacturing sites in Vienna, Austria), Biberach, Germany and Fremont, CA, "the disposable set-up is being installed at its mammalian cell culture sites in Biberach and Fremont.
Disposable technology is becoming more popular because it can eliminate some steps, providing pre-sterilized components, for example. However, a lack of standards has created some concerns among drugmakers. A survey from market researcher BioPlan Associates last year found that more than 40% of respondents identified the lack of "clear regulatory guidance on leachables and extractables" as keeping them from using disposables.
- here's the Outsourcing-Pharma story
- see the Manufacturing Chemist story
- get the InPharm story
- read the Boehringer Ingelheim release
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