The Flamma Group, a CDMO of small-molecule active pharmaceutical ingredients (APIs) and advanced cGMP intermediates, is proceeding with a $200-million investment plan over the next three years to expand its sites in Italy, the US, and China. Fabrice Cornille, Executive Director, Global Business, Flamma, provided an update at the DCAT Member Company Announcement Forum held on March 20, 2023, at DCAT Week. 

The company has a global footprint of five cGMP sites (three in Italy, one in China, and one in North America) and is proceeding with a $200-million expansion plan over the next three years as outlined below.  

In Italy: 

• Revamping, upgrading, and improving the recently acquired Bulciago site (650 m³). This large cGMP site with reactor vessels of significant volume is desinged as an option for those companies looking for additional capacities in Europe.  

• Additional improvements are currently ongoing at Flamma’s two other sites in Italy, Chignolo & Isso. These improvements include installation of new equipment, including reactors, filter dryers as well as distillation units. 

• To support its sustainability goals, the company is planning installation of solar panels as it looks for more opportunities in this area. 

In China:  

• Completion of several new GMP workshops at Flamma Honkai (Dalian, China).  

• Flamma Honkai will increase from 200 m³ of small-molecule API/new chemical entity (NCE) capacity to, initially, 400 m³ and then ultimately to 800 m³ as market demand increases. 

In the US:  

• Additional improvements to the API and high-potency API capabilities at Flamma USA include a new API cleanroom and renovated GMP kilo labs. 

• The installation of a 250-L hydrogenator is scheduled for late 2023. 

• Implementation of new technologies, such as flow chemistry, is being instituted across the company sites in Italy, China, and the US. 

• The continued development of Flamma USA (located near Philadelphia) provides the flexibility to begin early-stage small-molecule projects within the US and to then consider using the rest of the company’s network as the project grows.