Merck KGaA said today it will spend €35 million ($41 million) at its Bari manufacturing site in Modugno, Italy, to build a new production line for aseptic filling of biologics.
The new production line—which Merck said is expected to be fully operational in 2022—is intended for aseptic filling of biologics for multiple sclerosis, fertility, and endocrinology, with an annual production capacity of 14 million units.
The production line will be equipped with an isolator technology designed to ensure the safety of injectable medicines and will employ a “high level” of automation, Merck said.
“This investment underpins the importance of the Modugno-Bari production site for our growing Healthcare business,” Stefan Oschmann, Ph.D., Merck’s chairman of the executive board and CEO, said in a statement. “It will help us to secure the supply of medicines that improve people's lives around the world.
Antonio Messina, head of Merck's biopharmaceutical business in Italy, told news website BariLive.it: “With this further investment in technology and innovation, Modugno-Bari's website is a flagship for the industry of our country and for our group.”
Merck has requested funding for the new production line from officials in Italy’s Puglia (Apulia) Region, where the plant is located.
“The choice of Merck to invest in Puglia is a demonstration that our region is able to provide highly qualified staff at our universities, offering to major multinationals such as [Merck] standards of excellence, along with quality of life and a network of infrastructure capable of ensuring the portability of products across the world,” Puglia regional President Michele Emiliano told BariLive.it.
Merck KGaA can trace its history in Italy to a predecessor company more than a century ago. In 1906, Cesaro Serono—for whom Merck entity EMD Serono is named—founded the “Istitutio Farmacologico Serono” in Rome, specializing in the extraction and purification of natural substances. Merck acquired EMD Serono in 2007 and carries out biopharma operations under that name in the U.S. and Canada.
Merck's Bari manufacturing site opened in 1992, when it produced only lyophilized products for the Italian market. The site has since grown to specialize in fill and finish activities for multiple sclerosis, fertility, and endocrinology treatments marketed in more than 150 countries.
The Bari site is situated on 125,000 square meters (1,345,489 square feet), of which 25,000 square meters (269,098 square feet) are occupied by the facility. It consists of a production building, laboratories, a warehouse, services and utilities buildings, and a glass structure where administrative offices are located.
The site employs 225 people and is also involved in the manufacturing of some of Merck’s development-phase product candidates.
Bari is one of 15 Merck manufacturing sites focused on producing biologics and small-molecule pharmaceuticals. The company says its medicines treat 60 million patients worldwide.
In 2014, Merck spent €50 million (about $59 million) at the Bari site to build a fully automated production line using isolator technology, as well as an automated warehouse. The company won €10 million (about $12 million) in Puglia region funding toward that expansion.
Merck timed its announcement to an event celebrating the 25th anniversary of the Bari site and its importance in the development of science and technology industries in Puglia.