Tim Wright, Editor, Contract Pharma04.05.19
Pfizer CentreOne is a global contract development and manufacturing organization (CDMO) embedded within Pfizer. It provides custom API synthesis, sterile injectable fill-finish and highly potent oral solid dose manufacturing capabilities. Pfizer CentreOne is also a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, Pfizer CentreOne has manufactured complex compounds for its biopharmaceutical partners, guiding their drugs from development through commercialization. Contract Pharma talked with Pfizer CentreOne’s general manager, JoyL Silva, about some of the benefits the embedded CDMO model offers, small molecule trends in general, as well Pfizer CentreOne’s plans and predictions for future growth.
Contract Pharma (CP): How is Pfizer CentreOne ‘embedded’ in Pfizer?
JoyL Silva (JS): Businesses operating as embedded contract development and manufacturing organizations (CDMOs) are self-contained organizations that work within larger companies. They use all the assets and resources of a larger company to manufacture compounds or drug products for their partners.
As an embedded CDMO operating within Pfizer, we have access to Pfizer’s world-class facilities, technology and scientists to manufacture our partners’ products.
CP: How does Pfizer CentreOne compete with standalone CDMOs? What advantages does being part of a major pharmaceutical company offer?
JS: Put simply, being an embedded CDMO means that we can take advantage of Pfizer’s world leading capabilities. This means we have access to a global manufacturing network and some of the brightest scientific minds in the sector. We also follow stringent procedures to ensure the highest of quality standards, meaning we are a CDMO that our customers can trust to do the right thing.
We can also take advantage of Pfizer’s ability to make significant investments in its facilities. For example, Pfizer has invested $1 billion in its pharmaceutical manufacturing plant in Kalamazoo, MI over the last decade, adding to the impressive portfolio of facilities and resources that Pfizer already has.
In addition, at Pfizer CentreOne we have the capabilities and scale to take products from Phase IIb to commercialization, which helps to simplify the supply chain for our customers.
All our partners have a dedicated Pfizer CentreOne team made up of experts who can make the most of Pfizer’s resources, methods and capabilities.
CP: Are different manufacturing sites used to manufacture Pfizer products and Pfizer CentreOne partner products?
JS: No, one of the main advantages of partnering with Pfizer CentreOne is that our customers’ products are manufactured alongside Pfizer products, ensuring the highest quality standards and access to world leading technologies. This ultimately offers our customers peace of mind that their product is in safe hands.
Pfizer CentreOne manufactures its customers’ products out of Pfizer’s facilities at multiple sites, including Kalamazoo, Rocky Mount, Zagreb in Croatia, Melbourne in Australia, Newbridge in Ireland and Nagoya in Japan.
CP: Are clients concerned about handing over their IP to a Pfizer company?
JS: We take confidentiality very seriously. Because we have a mixed-use model, where both Pfizer and Pfizer CentreOne partner products are manufactured at the same sites, we have strict policies, processes, tools and training in place to protect IP. The IP we protect includes both Pfizer’s and Pfizer CentreOne partners’ patents, copyrights, trademarks, scientific and technical knowledge, know-how and experience.
Our commitment to confidentiality evidenced above means that we are seen as a safe pair of hands and we have earned the trust of our clients.
CP: In which area is Pfizer CentreOne observing the greatest growth from clients, and in which geographies are these firms based?
JS: At Pfizer CentreOne we are focused on providing specialty outsourced services to overcome complex manufacturing challenges and meet specific market demand. We are experiencing significant growth within our high potency oral solid dose (HP OSD) offering, particularly in the U.S. and Europe, as more potent compounds are being developed. High potency manufacturing requires special equipment, facilities and know-how, making outsourcing the preferred option for many companies developing these compounds. Pfizer continues to invest in its HP OSD facilities and our customers can take advantage of this. Our small molecule custom active pharmaceutical ingredient (API) offering is also in high demand as new and more challenging compounds enter the market.
CP: What should we be expecting from Pfizer CentreOne over the next five years? Expansion in terms of facilities/headcount/manufacturing areas? Or increased specialization?
JS: Our custom API offering is in high demand and we expect this side of our business to go from strength-to-strength over the next five years.
Of course, we will continue to leverage Pfizer’s facilities and capabilities so that we can offer our partners reliable support from Phase IIb right through to commercialization.
We are constantly evaluating the Pfizer network to see where there are opportunities for us to serve the market. Ultimately, we aim to address the development and manufacturing challenges faced by pharmaceutical companies today, as these challenges create the demand for outsourced capabilities and skills. Identifying these key areas and ensuring our offering is in line with market demand is our focus. In short, we must focus on delivering services that are of real value to pharmaceutical companies.
CP: What do you predict for the future of small molecule development? Combination therapies? More complex molecules?
JS: Firstly, small molecule products still make up a significant proportion of the market. While there is clear growth in biotech-based drugs, around 60%* of drugs in the current R&D pipeline are small molecule. This is reflected in the strong interest in our small molecule API capabilities and we expect this to continue.
In terms of custom API development and manufacturing, there is a trend towards green chemistry and API synthesis using bio routes. More specifically, there is a rise in manufacturing using fermentation to shortcut long synthetic routes. At Pfizer CentreOne, we offer organic synthesis, fermentation and particle sizing capabilities all from our Kalamazoo site, making us uniquely positioned to deliver greener chemistry, while also improving efficiencies and reducing costs.
CP: What other trends do you predict for 2019?
JS: Another trend we expect to see continue into 2019 is pharmaceutical companies reducing their small molecule manufacturing footprints. This will fuel the rise in outsourcing and demand for CDMOs.
Also, the high potency API market is experiencing significant growth, driven by demand for compounds to treat cancer, organ rejection and hormone products. In 2017 this segment of the market was valued at $16 billion and it is predicted to grow to $27 billion by 2023.**
As the market grows, so does regulatory scrutiny and the need for clear guidance. High potency manufacturing requires effective containment, cleaning and validation in order to protect the health of both workers and patients. With no clear, harmonized standards from regulators at present, manufacturers are currently left to develop their own strategies and methodologies to ensure the safe handling of HP APIs and meet regulatory expectations. Currently, there is a move from the traditional regulatory model to a health-based model, which will influence the industry’s approach to containment strategies as we head into 2019.
*Pharma R&D Annual Review 2018, Pharmaprojects, Pharma Intelligence, Informa
**Markets and Markets, April 2018
Contract Pharma (CP): How is Pfizer CentreOne ‘embedded’ in Pfizer?
JoyL Silva (JS): Businesses operating as embedded contract development and manufacturing organizations (CDMOs) are self-contained organizations that work within larger companies. They use all the assets and resources of a larger company to manufacture compounds or drug products for their partners.
As an embedded CDMO operating within Pfizer, we have access to Pfizer’s world-class facilities, technology and scientists to manufacture our partners’ products.
CP: How does Pfizer CentreOne compete with standalone CDMOs? What advantages does being part of a major pharmaceutical company offer?
JS: Put simply, being an embedded CDMO means that we can take advantage of Pfizer’s world leading capabilities. This means we have access to a global manufacturing network and some of the brightest scientific minds in the sector. We also follow stringent procedures to ensure the highest of quality standards, meaning we are a CDMO that our customers can trust to do the right thing.
We can also take advantage of Pfizer’s ability to make significant investments in its facilities. For example, Pfizer has invested $1 billion in its pharmaceutical manufacturing plant in Kalamazoo, MI over the last decade, adding to the impressive portfolio of facilities and resources that Pfizer already has.
In addition, at Pfizer CentreOne we have the capabilities and scale to take products from Phase IIb to commercialization, which helps to simplify the supply chain for our customers.
All our partners have a dedicated Pfizer CentreOne team made up of experts who can make the most of Pfizer’s resources, methods and capabilities.
CP: Are different manufacturing sites used to manufacture Pfizer products and Pfizer CentreOne partner products?
JS: No, one of the main advantages of partnering with Pfizer CentreOne is that our customers’ products are manufactured alongside Pfizer products, ensuring the highest quality standards and access to world leading technologies. This ultimately offers our customers peace of mind that their product is in safe hands.
Pfizer CentreOne manufactures its customers’ products out of Pfizer’s facilities at multiple sites, including Kalamazoo, Rocky Mount, Zagreb in Croatia, Melbourne in Australia, Newbridge in Ireland and Nagoya in Japan.
CP: Are clients concerned about handing over their IP to a Pfizer company?
JS: We take confidentiality very seriously. Because we have a mixed-use model, where both Pfizer and Pfizer CentreOne partner products are manufactured at the same sites, we have strict policies, processes, tools and training in place to protect IP. The IP we protect includes both Pfizer’s and Pfizer CentreOne partners’ patents, copyrights, trademarks, scientific and technical knowledge, know-how and experience.
Our commitment to confidentiality evidenced above means that we are seen as a safe pair of hands and we have earned the trust of our clients.
CP: In which area is Pfizer CentreOne observing the greatest growth from clients, and in which geographies are these firms based?
JS: At Pfizer CentreOne we are focused on providing specialty outsourced services to overcome complex manufacturing challenges and meet specific market demand. We are experiencing significant growth within our high potency oral solid dose (HP OSD) offering, particularly in the U.S. and Europe, as more potent compounds are being developed. High potency manufacturing requires special equipment, facilities and know-how, making outsourcing the preferred option for many companies developing these compounds. Pfizer continues to invest in its HP OSD facilities and our customers can take advantage of this. Our small molecule custom active pharmaceutical ingredient (API) offering is also in high demand as new and more challenging compounds enter the market.
CP: What should we be expecting from Pfizer CentreOne over the next five years? Expansion in terms of facilities/headcount/manufacturing areas? Or increased specialization?
JS: Our custom API offering is in high demand and we expect this side of our business to go from strength-to-strength over the next five years.
Of course, we will continue to leverage Pfizer’s facilities and capabilities so that we can offer our partners reliable support from Phase IIb right through to commercialization.
We are constantly evaluating the Pfizer network to see where there are opportunities for us to serve the market. Ultimately, we aim to address the development and manufacturing challenges faced by pharmaceutical companies today, as these challenges create the demand for outsourced capabilities and skills. Identifying these key areas and ensuring our offering is in line with market demand is our focus. In short, we must focus on delivering services that are of real value to pharmaceutical companies.
CP: What do you predict for the future of small molecule development? Combination therapies? More complex molecules?
JS: Firstly, small molecule products still make up a significant proportion of the market. While there is clear growth in biotech-based drugs, around 60%* of drugs in the current R&D pipeline are small molecule. This is reflected in the strong interest in our small molecule API capabilities and we expect this to continue.
In terms of custom API development and manufacturing, there is a trend towards green chemistry and API synthesis using bio routes. More specifically, there is a rise in manufacturing using fermentation to shortcut long synthetic routes. At Pfizer CentreOne, we offer organic synthesis, fermentation and particle sizing capabilities all from our Kalamazoo site, making us uniquely positioned to deliver greener chemistry, while also improving efficiencies and reducing costs.
CP: What other trends do you predict for 2019?
JS: Another trend we expect to see continue into 2019 is pharmaceutical companies reducing their small molecule manufacturing footprints. This will fuel the rise in outsourcing and demand for CDMOs.
Also, the high potency API market is experiencing significant growth, driven by demand for compounds to treat cancer, organ rejection and hormone products. In 2017 this segment of the market was valued at $16 billion and it is predicted to grow to $27 billion by 2023.**
As the market grows, so does regulatory scrutiny and the need for clear guidance. High potency manufacturing requires effective containment, cleaning and validation in order to protect the health of both workers and patients. With no clear, harmonized standards from regulators at present, manufacturers are currently left to develop their own strategies and methodologies to ensure the safe handling of HP APIs and meet regulatory expectations. Currently, there is a move from the traditional regulatory model to a health-based model, which will influence the industry’s approach to containment strategies as we head into 2019.
*Pharma R&D Annual Review 2018, Pharmaprojects, Pharma Intelligence, Informa
**Markets and Markets, April 2018
