Edition 3 / October 2021
Dr. Michael Quirmbach,
President & CEO,
Chief Operating Officer,
Dr. Stephen Houldsworth,
VP, Platform Management & Marketing, CPI
So Michael, as we sit here in mid-September 2021, perhaps we could start by providing a brief overview of how the year is going and then discuss what strategic decisions the organization has made with regards CAPEX and technology enhancements.
I am very pleased that we made the decision, together with the Platform Directors, Managing Directors, and Corporate Team, to invest into Lipid NanoParticle (LNP) formulation at our site in Caponago, further strengthen our peptide offering by offering GMP manufacturing clinical trial supply from our site in Frankfurt (Fechenheim, Germany), and further strengthen our solid dosage highly potent formulation capabilities, including commercial manufacturing, for our site in Plankstadt.
We then have other activities we have decided on, where Lee Newton will further give input.
So for example, in our (Small Molecule) Development Centre of Excellence in Liestal Switzerland, we will be adding capabilities in bioavailability enhancement, solid-state chemistry and formulation of oral solid dosage forms using purely soluble molecules.
This will also be supported by the Plankstadt site, which manufactures these oral solid dosage forms. There we’ll also be adding the capability for doing encapsulation, as well as tableting for highly potent compounds.
Coming back to Liestal, we will also be investing in supercritical fluid chromatography for purification of lipids. Some lipids are best purified that way, some by HPLC, so we will be able to choose the best technology.
Scale-up of the supercritical fluid chromatography will be done in our Chenôve France site. There we are also building up our Centre of Excellence in Flow Chemistry for continuous manufacturing, where some molecules are best made using that technology for either purity or safety reasons.
Moving to Italy, the Bergamo site will be getting a brand new development center. Here we recognize that for commercial manufacturing and commercialization of late clinical compounds, the demands of CMC sections are becoming ever more, and we are providing extra capability to provide that data to our customers to ensure that they get a secure and safe launch of their compounds.
Finally in Colorado in the US, we’ve already added this year, another hundred centimeter HPLC column, and we will be following that up with a downstream continuous manufacturing with liquid-liquid extraction and continuous distillation.
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