Denali signs Lonza to make biologics in first CMO deal
The firms announced the partnership – covering all stages of development manufacturing for clinical trials – for diseases such as Alzheimer’s, Parkinson’s and Amyotrophic Lateral Sclerosis (ALS).
Lonza Group will also be responsible for delivering finished drug products for patients, overseen by its in-house Drug Product Services in Basel, Switzerland.
“This is Denali’s first portfolio of drugs, and we will be their first clinical manufacturer,” said Lonza's Karen Fallen.
Fallen said the initial development work will be carried out at the contract manufacturing organisation’s (CMO’s) clinical development facility in Slough, UK.
“Denali will then have the option to produce clinical material in both Slough, UK and Hayward, CA, US.
“As Denali are based in California, they have the option of having production ‘on their back doorstep’ if needed,” she told us.
The Swiss CMO acquired the Hayward manufacturing facility from Shire in October last year, to cater for demand for mammalian cell culture-based drug production.
The site added early-phase clinical manufacture on the West Coast, as a complement to Lonza’s Slough facilities, said Fallen.
Denali said the partnership enables access to Lonza’s GS Xceed Gene Expression System, which the CMO claims creates cell lines up to six weeks, encourages improved cell growth, and faster doubling times than its predecessor.
