Kenneth Drew, Ph.D., Senior Director of North America Sales and Business Development
During a time when the Italian and Western European pharma market did not have commercial-grade amino acid manufacturers, Dr. Marco Negrisoli stepped in to solve the problem and together with his wife Dr. Edmea Killmann started a company called Flamma Group in 1950. The name Flamma came from “Fabbrica Lombarda Ammino Acidi,” which means a factory making amino acids in the Lombarda region of Italy. However, what started as a company that solely focuses on manufacturing amino acids today has transpired into a leading contract manufacturing organization (CMO).
In 1996, Flamma relocated to Chignolo d’Isola, Italy and under the leadership of Gian Paolo Negrisoli (Marco’s son), the company experienced rapid growth. Further, having determined that a China-based operation was in the company’s best interests, Gian Paolo established Shanghai Flamma in 2005, which was eventually moved to Dalian, China and was renamed to Flamma Honkai. Meanwhile, Flamma opened a sales office in Boston in 2010 and also acquired an additional manufacturing facility in Isso, Italy in 2012 as part of the company’s commercial strategy to expand its client portfolio.
Flamma provides a stable and secure supply chain for active pharmaceutical ingredients (APIs), new chemical entities (NCEs) and registered starting materials (RSMs) utilizing its state-of-the-art cGMP manufacturing facilities complete with research and development (R&D) staff and labs at all of their sites. Flamma additionally provides specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries. “Flamma is a trusted partner that helps accelerate the supply chain of pharma companies working to develop small molecules drugs,” explains Kenneth Drew, Ph.D., Senior Director of North America Sales and Business Development at Flamma.
The company provides the expertise for assisting its clients in early phase development as well as large-scale manufacturing. Flamma prides itself with the customer service they provide working with clients to solve problems such as completing a project earlier that initially planned to meet a client’s deadline. Superior service and flexibility are, in fact, what sets Flamma apart from the competition.
Some of Flamma’s capabilities include custom synthesis, process development and optimization, analytical validation, ICH stability studies, calorimetry studies, and safety risk assessments. To provide a better look into Flamma’s service offerings Drew mentions a case involving one of the top three pharma companies worldwide. The client had been developing a compound, which was in Phase 3 of the clinical trial. The cGMP intermediate involved a seven-step synthesis requiring the use of triphosgene and the inversion of chiral centers. Since the intermediate was a category 4 genotoxic compound, the pharma company needed relatively high levels of containment and Flamma’s infrastructure was more than suitable for this. Also, the compound was needed to be produced in large volumes while keeping the pricing at a minimum to remain competitive. The first four steps were performed at Flamma Honkai and telescoped for productivity and cost savings. The two metric ton campaign was successful with yield and quality exactly in line with lab trials. The remaining three steps were performed in Flamma Italy on a 1.1 metric ton scale campaign, which was also successful and had the same quality and yield that was obtained at lab scale.
Dedicated to delivering a fair price and on-time delivery, while maintaining specifications and quality, Flamma has been a recipient of numerous awards as a ground-breaking CMO. The company is also actively expanding its offerings and recently acquired the Teva’s Chemical Synthesis Centre in Malvern, PA (outside Philadelphia). The facility has been dubbed Flamma-delphia and contains a cGMP pilot plant, along with a variety of kilo labs (including a high potency kilo lab), an analytical development lab, and a quality control lab. Flamma-delphia will be dedicated to the development and production of small quantities of APIs ranging from pre-clinical/clinical phases up to its commercial phase. Currently, Flamma has over 600 employees, four different cGMP manufacturing sites, and four different R&D labs. As a part of its ongoing mission, the company remains dedicated to exceeding the expectations of its clients and building positive, rewarding, and long lasting relationships.