The facility in Frederick, Maryland is set to benefit from an injection of more than $200m, the company said, in order to increase production capacity ready for AstraZeneca’s pipeline to come to fruition.
The firm says almost half its drugs in development are currently biologics, and this is set to grow, echoing other Big Biopharma including Bristol-Myers Squibb which predicted 75% of its pipeline would be biologics by 2019.
“Biologics are an important part of AstraZeneca’s overall capabilities,” regional vice president of biologics supply for AstraZeneca, Andrew Skibo, said. “Our global biologics research and development arm, MedImmune, has a robust pipeline of more than 120 biologics, including more than 30 in clinical development.”
He continued, adding this expansion will “support the progression of drug candidates across [its] core therapeutic areas,” following its expected completion in mid-2017.
The commercial cell culture production facility was last expanded in 2006 by MedImmune – since acquired for $15.6bn and incorporated as the global biologics research and development arm of AstraZeneca – when $250m was invested adding two commercial stainless steel bioreactors to, in part, increase volumes of childhood respiratory drug Synagis (palivizumab).
Along with Frederick, AstraZeneca has biologics capabilities in Philadelphia (Pennsylvania), Speke (UK), and Nijmegen in the Netherlands.
In-house biologics
We asked AstraZeneca why it had chosen to invest in its own capabilities for biologics rather than use a third-party manufacturer.
"Our robust biologics pipeline in particular requires a very flexible and responsive supply chain for bulk drug substance production for clinical and launch/early market supply, which can more easily be delivered through an internal network," spokesperson Alisha Martin told us. "The investment in our Frederick, Maryland site is a critical component in that plan and will enable us to secure long-term, global product supply."
"There are inherent differences in the manufacture of small molecule products vs. biologics that are factored into the long-term strategic planning," she continued. "As a large, global manufacturer of a variety of therapeutic products, our overarching strategy continues to be a supplier of high-quality, reliable, and timely medicines to global patients who need them."
This expansion follows a number of other Big Biopharma firms which have invested in their own biologics-making operations. Amgen opened its single-use biomanufacturing facility in Singapore last week, and BMS announced plans to build a $900m commercial facility in Ireland.
Furthermore, Novartis – which is constructing a $500m cell-culture based facility in Singapore – prefers to invest in-house for complex manufacturing, like biologics, rather than use a contract manufacturing organisation (CMO), according to comments from its head of global tech operations at a conference last week.
These views mirror those of Eli Lilly and Janssen, which have both told this publication they are reluctant to lose control of their biologics manufacture through outsourcing.