Merck KGaA, Darmstadt, Germany, said today it will carry out a €150 million ($168 million) expansion of its biologics manufacturing site at Aubonne, Switzerland, designed to help meet the growing demand for treatments by increasing its production capacity.
The expansion over the 2019–2023 period will entail construction of a third building dedicated to Merck KGaA biotech medicines destined for more than 150 countries.
Among products Merck KGaA said it anticipates manufacturing there are:
- The fertility treatment Gonal-f® (follitropin alfa for injection)
- The programmed cell death ligand-1 (PD-L1) checkpoint inhibitor Bavencio® (avelumab) co-developed with Pfizer under a partnership launched in 2014
- Drug candidates now in clinical development such as M7824 (bintrafusp alfa), the cancer immunotherapy being developed with GlaxoSmithKline through a collaboration that could generate more than €3.7 billion ($4.2 billion) for German Merck
The new building will be equipped with technologies dedicated to aseptic filling and quality control, as well as what Merck KGaA termed an innovative design and a flexible operations model to deliver increased productivity.
New lines for the aseptic filling of biotech medicines will be equipped with isolator technology, in order to ensure the safety of injectable medicines. One line will be dedicated to freeze-dried formulations, the other to liquid formulations. The two new fill lines, as well as the new quality control labs, will replace existing infrastructure, and enable the plant to produce up to 27 million vials per year.
Validation expected by 2023
Construction of the new building is expected to be completed in 2020, with the new quality control labs operational in 2021 and the new lines for aseptic filling in 2023, following validation by regulators.
“This investment reflects our commitment to ensuring that our medicines always meet the highest quality standards and are readily available to patients all over the world whenever they need them,” Belén Garijo, member of the Executive Board of Merck KGaA and CEO Healthcare, said in a statement. “It is an expression of our confidence in the future growth of our Healthcare business sector.”
Merck KGaA opened the Aubonne site in 1984. Two years ago, the company completed a CHF 27 million ($27.1 million), 8,000-square-meter (approximately 86,000-square-foot) packaging center that was projected at capacity to process over 12 million boxes of medication and four million auto injectors per year.
Aubonne is one of Merck KGaA’s 11 locations in Switzerland, and one of the company’s two main manufacturing locations there; the other is in nearby Vevey. The Aubonne and Vevey sites are among 18 manufacturing sites worldwide where Merck KGaA produces biotech and pharmaceutical medicines for some 70 million patients worldwide.
Merck KGaA employs 2,300 of its approximately 52,000 employees across Switzerland, which is the company’s prime hub for biologics manufacturing—and where more than CHF 1 billion ($1.004 billion) has been invested over the past 10 years. Merck KGaA has blamed negative foreign exchange rates for its 10.5% year-over-year decline last year in earnings before interest taxes, depreciation, and amortization before one-time items (EBITDA pre) of €3.8 billion, (about $4.3 billion) on €14.8 billion ($16.6 billion) in group sales, up 2.2% from 2017.