The facility in Södertälje is set to be operational and producing clinical trial materials by the end of 2018, while finished biologics on a commercial scale will come on-line the following year, the Anglo-Swedish Pharma Giant said yesterday.
“This is a multi-product facility,” AstraZeneca spokesman Jacob Lund told Biopharma-Reporter.com, with “filling and packaging capability focused on [our] biologic pipeline across our therapy areas,” and for all global markets.
With more than 30 biologics in development, over half of AstraZeneca’s pipeline is made up of large molecules, consistent with Big Pharma’s shift away from small molecule drugs. For example, up to 75% of Bristol-Myers Squibbs’ potential candidates will be biologics by 2019, the firm predicted.
This $285m investment will help ensure AstraZeneca has greater capacity and flexibility to support the shift to biologics, and - according to Lund - will be equipped with the latest technologies consistent with process assurance to help ensure this.
“The site will need be to be extremely agile and responsive. Single use disposables will help us to respond effectively to mix in the pipeline.”
Up to 200 new jobs will be created once the facility is up and running, helping bolster Sweden’s image as a biomanufacturing hub. Pfizer, Cobra, Kemwell and Octapharma all have sites in the country, and according to AstraZeneca President Jan-Olof Jacke, the sector has been “encouraged by signals from the Swedish Government regarding a competitive and supportive environment for business investment.”
Network resilience
The investment is the second boost to AstraZeneca’s biologics pipeline in six months after the firm – through its biologics subsidiary MedImmune – ploughed $200m into a site in Frederick, Maryland.
Despite investing in its own capabilities, Lund said the firm would continue to use contract manufacturing organisations (CMOs) where necessary.
“Internal capability is strategically important and that is why we are developing this new facility,” he said. “We already have relationships with third parties and will continue to ensure there is business resilience in the network.”