Tim Wright, Editor, Contract Pharma10.15.19
Flamma SpA, a contract development and manufacturing organization (CDMO) that develops, manufactures, and commercializes small molecule active pharmaceutical ingredients (APIs) for the pharmaceutical industry, acquired Teva’s Chemical Synthesis Center in Malvern, PA in the Philadelphia area, earlier this year in July.
Dubbed “Flamma-delphia,” the 40,000 square foot facility, with lab and manufacturing capabilities, possesses a cGMP pilot plant with hydrogenation capabilities as well as wet-milling, six standard cGMP kilo lab suites, one cGMP HPAPI kilo lab suite with isolators that have been classified 3b (Roche) or band 4 (Safebridge), 22 fume hoods, an analytical development lab, as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs. Also, the site previously handled controlled drug substances (Schedule II to IV) and Flamma says it looks forward to reactivating the necessary licenses.
This site will initially be dedicated to the development and production of APIs ranging from preclinical/clinical (Phases 1 to 3) and up to commercial phase (after future FDA inspection) with the scale being dependent on the forecasted quantities. Flamma plans to grow the site to 60 employees by 2023.
This acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug manufacturing license from the Chinese FDA. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high containment lab to handle genotoxic materials. Flamma intends to invest approximately $10 million to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.
Recently, Contract Pharma had the chance to talk with Ken Drew, Flamma’s senior director of North America sales and business development about the facility purchase and other company news, as well as larger industry trends.
Contract Pharma (CP): What was the strategy behind the acquisition of Teva’s facility?
Ken Drew (KD): Flamma had been looking to have a location in the U.S. for the past several years. While many in the CDMO industry grew by consolidation, Flamma decided not to overreact and continue to look for a facility that was a good fit. The Teva facility allows Flamma to quickly move to a position where we can offer cGMP pilot plant scale projects in the U.S. while maintaining our fully integrated system for customers looking to have a secure supply chain. Having sites in Italy and China and now the U.S., Flamma can provide a variety of options for our customer base.
CP: What capabilities does the new facility provide and how will it foster future growth for Flamma?
KD: Flamma will continue to be true to itself and do what we do best. The consolidation of CDMOs to include drug product along with drug substance is something that we don’t feel is necessary to provide quality service. Flamma can now provide those companies that want to remain close to home in the U.S., a place to take early stage development projects. The projects with quantities from 1-20 kg seem to be a perfect fit. These can be APIs, RSMs, NCEs, or advanced intermediates.
It also allow us to continue to grow our niche generic portfolio that takes advantage of our skill set with high value amino acid derivatives. We also have a new R&D team that is ready to be part of the already fantastic R&D team.
“Flamma-delphia” on the inside. (Credit: Flamma)
CP: In which area is Flamma observing the greatest growth from clients, and in which geographies are these firms based?
KD: It is difficult to determine where the greatest growth is coming from since our customer base combines new customers along with old customers who consider Flamma a preferred supplier or their “go to” CDMO. We are seeing customers from the U.S., Europe, and Asia come to us with projects that seem to fit well with our small molecule toolbox.
CP: What do you predict for the future of small molecule development? Combination therapies? More complex molecules?
KD: It is clear that small molecules are becoming more complex. The days of a simple five step synthesis are over. We are seeing molecules that require very advanced intermediates that often come from numerous synthetic steps. We like to back integrate projects so, if we can, we will look to Flamma Honkai, our facility in Dalian, China, to see if we can bring value by making the materials in house and simplifying the supply chain.
By bringing this value forward, we gain a greater control over the supply chain for the customer who, in turn, can either have Flamma continue to make the material for them or use our costing and scheme to have it made elsewhere. This frees up our internal resources to work on more advanced materials for customers.
The move, when appropriate, toward flow chemistry is still very interesting and is something Flamma is undertaking. The issue is that not every synthetic scheme lends itself to flow chemistry so batch chemistry will continue to be part of the toolbox any CDMO uses.
CP: What are some of the crucial issues impacting pharma manufacturing and supply and CDMOs in particular?
KD: One of the most critical issues that many people are overlooking is the potential shortage of basic chemicals. The environmental changes in China have caused many companies that made simple basic materials and solvents to close. This has caused the cost of many so-called common materials and solvents to increase dramatically in price and become in short supply.
Flamma has been very proactive in either stocking more materials and solvents where we see potential shortages as well as sourcing from multiple suppliers to decrease the risk of shortages. Customers will not tolerate, and should not tolerate, the excuse that our supplier was late or short of material. It’s our job to make sure we do our job as best as we can.
CP: How are partnerships in external development and manufacturing evolving, and what does the future hold?
KD: The consolidation of the CDMO industry has been discussed ad nauseam. That said, it has also provided innovators a look at how they outsource their small molecules. For Flamma, consolidation has been great since our customers value the family run, family owned business model that we have.
Customers are looking for long term relationships and partnerships. Becoming part of a preferred supplier list or considered the CDMO that solves problems as opposed to making them is what Flamma strives to be. Full transparency not only in the way we handle projects but in the way we provide quotes allows a customer to see what exactly is going on. Raw material table breakdowns allow customers to compare apples to apples.
By giving a fair price along with realistic time lines and then delivering on time and in spec is what we do. Those experienced sourcing managers realize that the size of the CDMO and the project’s costs need to be evaluated against the track record and reputation of the CDMO.
CP: What demand are you seeing for the outsourcing of small molecules? Why strengthen in this space?
KD: Small molecules are not going away. They are being used in many different facets. They are being used in new drug delivery systems, ADCs, etc. While they are becoming more complex, the innovators need to understand the CDMO marketplace and realize who has the ability to handle their molecules. Flamma’s experience dates back to 1950. That experience translates to the ability to handle sophisticated molecules such as ones that are high value chiral molecules like amino acids.
The need is there, and having a fully integrated CDMO that can go from small kilos to metric tons, from the U.S. to Italy and/or China to Italy is needed.
CP: In addition to the newly acquired facility, what are some other business highlights from the past 12 months?
KD: Flamma’s Dalian, China site, Flamma Honkai, had its initial Chinese FDA inspection and we also acquired additional land for our expansion plans there. These important milestones allow us to build upon our successes as Flamma continues to service our customers.
Flamma also completed construction of a cGMP kilo lab at our Chignolo D’Isola headquarters in Italy. Customers looking for a CDMO with a long-term vision that is transparent have embraced Flamma’s vision.
CP: What is next for Flamma?
KD: Flamma has also purchased parcels of land at both Italian sites to allow for future expansion such as the new R&D building at Chignolo D’Isola headquarters scheduled to start construction later this year. This $10 million addition will provide a new R&D building that will quadruple our R&D space. This will allow Flamma to continue to grow our staff of researchers that serve the pharma industry, the demands of our current customers as well as future customers.
As mentioned previously, Flamma Honkai will look to expand on the land acquired there with the addition of another workshop as we smartly expand to meet the demands made by customers.
CP: What else can you tell us about Flamma?
KD: Flamma is a family owned, family run company since its beginnings and because of this, Flamma’s culture is very much like a family. Each and every employee regardless of their location is part of the Flamma family and culture. We think that the combination of our family spirit, which also embraces harmony and respect, along with our competent and strong scientific background, will continue to allow us to successfully grow as a leader in the small molecule CDMO arena.
Flamma always tries to build long-term partnerships that are an extension of the customer’s team. By having the same team follow a project from the start gives customers a certain piece of mind that Flamma carries an internal knowledge of the project. This helps to solve issues quickly. We are not a pair of hands but the Thinking CDMO. We help solve problems by working simultaneously together.
Kenneth N. Drew, Ph.D., is the Sr. Director of North America Sales and Business Development for Flamma. He joined Flamma in January 2010 as the first employee of Flamma USA. Before joining Flamma, he worked for Cambrex in a similar role. As a Ph.D. chemist, he worked in the lab for 20 years at places like Biogen before moving into the business side of the pharma industry. In these lab positions, he helped to develop a variety of drugs for colon cancer, congestive heart failure, and many others. This knowledge of what it takes to develop a drug has served him well when dealing with customers looking to place small molecule projects for CMC.
Dubbed “Flamma-delphia,” the 40,000 square foot facility, with lab and manufacturing capabilities, possesses a cGMP pilot plant with hydrogenation capabilities as well as wet-milling, six standard cGMP kilo lab suites, one cGMP HPAPI kilo lab suite with isolators that have been classified 3b (Roche) or band 4 (Safebridge), 22 fume hoods, an analytical development lab, as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs. Also, the site previously handled controlled drug substances (Schedule II to IV) and Flamma says it looks forward to reactivating the necessary licenses.
This site will initially be dedicated to the development and production of APIs ranging from preclinical/clinical (Phases 1 to 3) and up to commercial phase (after future FDA inspection) with the scale being dependent on the forecasted quantities. Flamma plans to grow the site to 60 employees by 2023.
This acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug manufacturing license from the Chinese FDA. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high containment lab to handle genotoxic materials. Flamma intends to invest approximately $10 million to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.
Recently, Contract Pharma had the chance to talk with Ken Drew, Flamma’s senior director of North America sales and business development about the facility purchase and other company news, as well as larger industry trends.
Contract Pharma (CP): What was the strategy behind the acquisition of Teva’s facility?
Ken Drew (KD): Flamma had been looking to have a location in the U.S. for the past several years. While many in the CDMO industry grew by consolidation, Flamma decided not to overreact and continue to look for a facility that was a good fit. The Teva facility allows Flamma to quickly move to a position where we can offer cGMP pilot plant scale projects in the U.S. while maintaining our fully integrated system for customers looking to have a secure supply chain. Having sites in Italy and China and now the U.S., Flamma can provide a variety of options for our customer base.
CP: What capabilities does the new facility provide and how will it foster future growth for Flamma?
KD: Flamma will continue to be true to itself and do what we do best. The consolidation of CDMOs to include drug product along with drug substance is something that we don’t feel is necessary to provide quality service. Flamma can now provide those companies that want to remain close to home in the U.S., a place to take early stage development projects. The projects with quantities from 1-20 kg seem to be a perfect fit. These can be APIs, RSMs, NCEs, or advanced intermediates.
It also allow us to continue to grow our niche generic portfolio that takes advantage of our skill set with high value amino acid derivatives. We also have a new R&D team that is ready to be part of the already fantastic R&D team.
“Flamma-delphia” on the inside. (Credit: Flamma)
CP: In which area is Flamma observing the greatest growth from clients, and in which geographies are these firms based?
KD: It is difficult to determine where the greatest growth is coming from since our customer base combines new customers along with old customers who consider Flamma a preferred supplier or their “go to” CDMO. We are seeing customers from the U.S., Europe, and Asia come to us with projects that seem to fit well with our small molecule toolbox.
CP: What do you predict for the future of small molecule development? Combination therapies? More complex molecules?
KD: It is clear that small molecules are becoming more complex. The days of a simple five step synthesis are over. We are seeing molecules that require very advanced intermediates that often come from numerous synthetic steps. We like to back integrate projects so, if we can, we will look to Flamma Honkai, our facility in Dalian, China, to see if we can bring value by making the materials in house and simplifying the supply chain.
By bringing this value forward, we gain a greater control over the supply chain for the customer who, in turn, can either have Flamma continue to make the material for them or use our costing and scheme to have it made elsewhere. This frees up our internal resources to work on more advanced materials for customers.
The move, when appropriate, toward flow chemistry is still very interesting and is something Flamma is undertaking. The issue is that not every synthetic scheme lends itself to flow chemistry so batch chemistry will continue to be part of the toolbox any CDMO uses.
CP: What are some of the crucial issues impacting pharma manufacturing and supply and CDMOs in particular?
KD: One of the most critical issues that many people are overlooking is the potential shortage of basic chemicals. The environmental changes in China have caused many companies that made simple basic materials and solvents to close. This has caused the cost of many so-called common materials and solvents to increase dramatically in price and become in short supply.
Flamma has been very proactive in either stocking more materials and solvents where we see potential shortages as well as sourcing from multiple suppliers to decrease the risk of shortages. Customers will not tolerate, and should not tolerate, the excuse that our supplier was late or short of material. It’s our job to make sure we do our job as best as we can.
CP: How are partnerships in external development and manufacturing evolving, and what does the future hold?
KD: The consolidation of the CDMO industry has been discussed ad nauseam. That said, it has also provided innovators a look at how they outsource their small molecules. For Flamma, consolidation has been great since our customers value the family run, family owned business model that we have.
Customers are looking for long term relationships and partnerships. Becoming part of a preferred supplier list or considered the CDMO that solves problems as opposed to making them is what Flamma strives to be. Full transparency not only in the way we handle projects but in the way we provide quotes allows a customer to see what exactly is going on. Raw material table breakdowns allow customers to compare apples to apples.
By giving a fair price along with realistic time lines and then delivering on time and in spec is what we do. Those experienced sourcing managers realize that the size of the CDMO and the project’s costs need to be evaluated against the track record and reputation of the CDMO.
CP: What demand are you seeing for the outsourcing of small molecules? Why strengthen in this space?
KD: Small molecules are not going away. They are being used in many different facets. They are being used in new drug delivery systems, ADCs, etc. While they are becoming more complex, the innovators need to understand the CDMO marketplace and realize who has the ability to handle their molecules. Flamma’s experience dates back to 1950. That experience translates to the ability to handle sophisticated molecules such as ones that are high value chiral molecules like amino acids.
The need is there, and having a fully integrated CDMO that can go from small kilos to metric tons, from the U.S. to Italy and/or China to Italy is needed.
CP: In addition to the newly acquired facility, what are some other business highlights from the past 12 months?
KD: Flamma’s Dalian, China site, Flamma Honkai, had its initial Chinese FDA inspection and we also acquired additional land for our expansion plans there. These important milestones allow us to build upon our successes as Flamma continues to service our customers.
Flamma also completed construction of a cGMP kilo lab at our Chignolo D’Isola headquarters in Italy. Customers looking for a CDMO with a long-term vision that is transparent have embraced Flamma’s vision.
CP: What is next for Flamma?
KD: Flamma has also purchased parcels of land at both Italian sites to allow for future expansion such as the new R&D building at Chignolo D’Isola headquarters scheduled to start construction later this year. This $10 million addition will provide a new R&D building that will quadruple our R&D space. This will allow Flamma to continue to grow our staff of researchers that serve the pharma industry, the demands of our current customers as well as future customers.
As mentioned previously, Flamma Honkai will look to expand on the land acquired there with the addition of another workshop as we smartly expand to meet the demands made by customers.
CP: What else can you tell us about Flamma?
KD: Flamma is a family owned, family run company since its beginnings and because of this, Flamma’s culture is very much like a family. Each and every employee regardless of their location is part of the Flamma family and culture. We think that the combination of our family spirit, which also embraces harmony and respect, along with our competent and strong scientific background, will continue to allow us to successfully grow as a leader in the small molecule CDMO arena.
Flamma always tries to build long-term partnerships that are an extension of the customer’s team. By having the same team follow a project from the start gives customers a certain piece of mind that Flamma carries an internal knowledge of the project. This helps to solve issues quickly. We are not a pair of hands but the Thinking CDMO. We help solve problems by working simultaneously together.
