Novartis Making Moves to Increase Biologics Manufacturing Capability

The number of biologic drugs is increasing, and as they begin to account for a larger percentage of pharmaceutical companies’ portfolios, investments in new biologics production facilities are taking center stage. Novartis broke ground in February 2013 on its new $500-million biologics facility in Singapore, which underlies the company’s long-term strategy to establish a worldwide manufacturing network of technology centers of excellence. The facility is colocated with Novartis’ pharmaceutical production site in Tuas, Singapore and will focus on drug-substance manufacturing based on cell-culture technology. In addition, the investment represents a strategic commitment to Novartis’ growing biologics portfolio, which represents 25% of the company’s current clinical pharmaceutical research pipeline.

Strategic location
“Singapore’s marked biomedical presence and regional knowledge, well-trained talent, and proximity to Asian growth markets makes it a strategic location for biotechnological research and advancement,” says a Novartis spokesperson, who notes that Singapore is a well-regulated, secure environment in which Novartis can operate. The company recognizes Singapore’s value as a center of technology excellence and has partnered with the Singapore Economic Development Board since its establishment in 2002. Novartis also has several other ongoing operations in the country, including the Novartis Institute for Tropical Diseases, the Novartis Asia-Pacific head offices, two production facilities for its eye-care subsidiary Alcon, and a pharmaceutical manufacturing site. With the completion of the biologics facility, Novartis will have more than 1500 associates based in Singapore. Novartis began construction of this Singapore biologics plant earlier in 2013, and the production facility is expected to be fully operational by the end of 2016.

Focus on cell-culture technology
The facility will focus on drug-substance manufacturing based on cell-culture technology. The plant will be designed with the capability to support clinical and commercial production of potential new products, including monoclonal antibodies for use in the treatment of autoimmune, respiratory, and oncology diseases.

The importance of flexibility
The site will be designed to operate in a flexible manner in order to handle small and large-scale volumes, according to a Novartis spokesperson. Novartis will use a mix of disposable technology and stainless-steel systems placed in modules in an effort to get a high degree of repetition of design and automation. Multiple commercial-scale bioreactors with adjacent seed trains and corresponding purification lines will be designed and installed. In addition, the purification lines will be constructed in a flexible manner so as to be able to combine the purification steps in the order needed for specific therapeutic proteins. “With the equipment we are installing, the plant will produce material for clinical trials of biologics in the Novartis biopharmaceutical pipeline on the same scale as will be expected for commercial production,” the spokesperson notes.

Building a biologics portfolio
Two key biologic drugs in the Novartis product portfolio include Lucentis (ranibizumab), an anti-VEGF (vascular endothelial growth factor) therapy licensed for vision-related diseases developed in collaboration with Genentech/Roche, and Xolair (omalizumab), an anti-IgE antibody treatment for persistent allergic asthma for which Novartis also shares marketing rights with Genentech/Roche. Both drugs have reached blockbuster status, according to Novartis.

The investment in Singapore comes on the heels of the recent acquisition (late 2012) by Novartis of Dendreon’s FDA-approved Provenge plant in New Jersey, which is designed for the production of clinical and commercial quantities of Novartis’ CTL019 Chimeric antigen receptor and other human autologous cellular immunotherapy products. In December 2011, Novartis also began production of cell-culture based influenza vaccines at a new plant in North Carolina.