AstraZeneca and Recipharm Partner for Biomanufacturing Facility

AstraZeneca has announced the divestment of the AstraZeneca Biotech Laboratory (ABL) in Södertälje, Sweden, to Recipharm AB of Sweden, a contract development and manufacturing organization. Under the terms of the agreement, Recipharm Biotech AB (a newly formed subsidiary of Recipharm) will lease the ABL from AstraZeneca for an initial period of 12 years. Recipharm Biotech will also purchase all associated equipment, and the majority of the existing ABL staff will transfer their employment to Recipharm Biotech. AstraZeneca will retain a significant minority stake in the new company in addition to entering into a supply arrangement for Phase 1 and Phase 2 material for one of its development projects. No financial terms were disclosed. This acquisition by Recipharm follows the company’s recent purchase (August 2008) of lyophilization facilities from Inotech Labor AG (Basel, Switzerland). The handover date for the facility is set for 1 January 2009.

The divestment of the ABL follows AstraZeneca’s recent acquisition of MedImmune, through which it gained extensive biotechnology manufacturing capabilities. As a result, AstraZeneca has consolidated all biotech activities at MedImmune’s sites in the UK and the US.

The ABL is a pilot plant facility built for the small-scale development and supply of recombinant proteins and monoclonal antibodies in clinical trials and regulatory approvals. The facility holds a GMP and import license from the Swedish regulatory authorities for the production of recombinant biological products in bulk using mammalian cells. The multi-purpose facility offers both fed-batch and continuous perfusion culture, where up to 1,000 L of culture supernatant can be purified to a bulk drug substance per week. There are also plans in place to increase its fed-batch production capacity and to increase the plant’s flexibility by installing a new suite of 250- to 1,000-L disposable bioreactors. The facility’s automated cell-line development system enables it to develop high titer cell-lines rapidly and cost-effectively. These capabilities are complemented by comprehensive analytical expertise including advanced mass spectrometry services for protein characterization and comparability studies.