Novartis Pharma is carrying out a major expansion of its biotechnology centre in Huningue, France. Announced in August 2016, the expansion project will increase the facility’s monoclonal antibody (mAb) production capacity by 70%.

Investment in the Huningue facility is aimed at capitalising on the strategic importance of its location in France. The expansion will enable the facility to meet the anticipated growth of products already being manufactured at the site.

A $100m investment will be made for the project, which is expected to be completed by 2020.

Huningue Biotechnology Centre history

Inaugurated in 2005, the Huningue facility is fully GMP-compliant and Novartis’ main site for the production of monoclonal antibodies for the global market. Since the start of operations, Novartis has invested €215m ($240m) to equip the facility with advanced facilities and specialised infrastructure.

The facility initially started with a single antibody and has now become one of the world’s biggest producers of active substances by mammalian cell culture. It exports approximately 80% of production to the world market.

Active substances produced by the facility are used for the composition of drugs indicated for the treatment of asthma, psoriasis, renal transplantation and anti-inflammation. The facility also produces active substances required for Novartis’ clinical studies. Clinical batches of new monoclonal antibodies in development are also produced at the facility.

The facility was expanded in 2011 to enable production of anti-rejection drugs for kidney transplants. In 2012, Novartis invested another €6.2m ($6.9m) in equipment and infrastructure upgrades to increase production flexibility and capacity of the facility.

The Huningue facility manufactured active ingredients equivalent to three million doses in 2012.

Details of the expansion project

The expansion project will extend the main production building and install new cell culture bioreactors. It will also add a new purification line, which will enable multiple drugs to be produced simultaneously.

Installation of the production facilities is expected to be completed by January 2017, while commercial activities expected to commence in December 2018.

The expansion is expected to generate 100 jobs at the site.

Existing equipment and systems installed at the Huningue facility

The Huningue facility is equipped with 13 bioreactors of 500l each for the production of antihistamine, Xolair. It also features disposable equipment including bags for media and buffer storage. Disposable bags are used for intermediate storage of product as well as final storage of the drug. A fully-disposable filter system including disposable connectors and tubing is also part of the facility.

The facility is equipped with DeltaV™ digital automation system supplied by Emerson Process Management. Installed in 2005 and upgraded from 2008 to 2010, the system features an integrated Wi-Fi network and mobile operator stations. It provides process and plant information to operators and maintenance crew of the facility. The system also helps in improving efficiency and flexibility of production process across the plant.

Contractors involved

Jacobs Engineering Group has been awarded the engineering, procurement and construction management contract for the project.

Marketing commentary

Expansion of the Huningue facility is part of a major overhaul of Novartis’ operations. Overreaching operations and generic competition has eroded the company’s revenues. Sales of Gleevec, one of Novartis’ blockbuster mAbs, have fallen considerably owing to generic competition.

Focus on cutting costs and increasing the production of biosimilar products has been Novartis’ strategy over the last few years. The company has closed down more than two dozen of its manufacturing facilities and is also streamlining its research and development (R&D) activities. These moves are expected to reduce annual costs by $1bn by 2020.

In 2015, Novartis announced its decision to invest €800m ($890m), including €100m ($111.9m) annually in R&D over a three-year period. Novartis has also increased its focus on the production of biosimilars and plans to apply regulatory filings for at least 11 biosimilars by the end of 2017.