With the the coming entry of biosimilars in the U.S. and expansion of that market in Europe, biologic drugs are going to be in greater demand, as will the contract manufacturers who can supply the cell lines and special services needed to get them to market. Okalahoma-based Cytovance Biologics is joining a number of CMOs that are adding capacities to tap that growth.
The contract manufacturer of mammalian and microbial biologics says its has kicked off a project to expand both its manufacturing and warehousing near its current site in Oklahoma City. It didn't put a specific dollar value on the project, only that it will cost "multi-millions" of dollars. It expects to have it complete by the first half of this year.
The project will include microbial, mammalian and fill/finish capabilities with the addition of a new 1000-liter microbial fermenter, an automated fill/finish machine and a 2,500-liter stainless steel bioreactor. The project includes 20,000 square feet of climate-controlled and monitored warehouse space, as well as another 10,000 square feet for future expansion. It will use that cleanroom space initially for weighing and dispensing activities.
This is the second expansion project the company has undertaken in the last year. In January 2013, it announced plans to add a 1,000-liter single use bioreactor, a 5,000-liter stainless steel bioreactor and an automated fill/finish line.
Drugmakers like Roche ($RHHBY), which is producing significant numbers of cell-based products, have been expanding their biologics manufacturing capabilities. The Swiss drugmaker last year announced plans for nearly $900 million in investments in its manufacturing network globally to prepare for growing sales of existing products and to prepare for all of the biologic products in its pipeline. But many drug companies will be looking for someone else to provide the manufacturing expertise needed to produce these complex large-molecule drugs, and contract manufacturers are positioning themselves to catch the various portions of that business.
St. Louis, MO-based Sigma-Aldrich ($SIAL) last fall announced it was adding commercial-scale antibody-drug conjugate (ADC) manufacturing at a facility in St. Louis and expanding its high-potency active pharmaceutical ingredient (HPAPI) manufacturing and storage at its Verona facility near Madison, WI. Sweden-based Recipharm is spending €32 million ($43.4 million) to expand its lyophilization capabilities at a plant in Germany.
- here's the announcement