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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.
The Brazilian rainforest is one of the world’s most biodiverse regions and a center for phytochemistry, in which indigenous plants are harvested and their chemicals extracted for use as pharmaceutical APIs. Optimizing the process of gathering, harvesting, and extracting phytochemicals depends on the use of sustainable harvesting practices and modern business and manufacturing processes.
Centroflora CMS, a joint venture between phytochemicals expert Centroflora from Brazil and the Swiss contract manufacturing organization (CMO) CMS Pharma, specializes in phytochemical processing. In 2015, the company was recognized for the way it handled its acquisition and technical transfer of Boehringer Ingelheim’s (BI) non-captive phytochemical API portfolio in 2014. This work won the company CPhI’s 2015 Award for Excellence in Partnering and Outsourcing, which was presented at CPhI Worldwide in Madrid in October 2015.
Andrew Badrot, founder and CEO of Centroflora CMS, discussed the project’s scope and challenges with Pharmaceutical Technology.
Technical transferPharmTech: What were some of the reasons BI chose Centroflora CMS?
Badrot: Securing this complex business and executing the technology transfer was crucial because several of the APIs involved are used to make life-saving medicines. The chosen partner would be responsible for ensuring supply continuity but would also have to deliver additional services and support for related products. Centroflora CMS offered three benefits: phyto API manufacturing capability, the outsourcing expertise required to manage the API technical transfer, and the ability to take over all business activities.
PharmTech: What were some of the keys to ensuring the successful technical transfer of BI’s API phyto product portfolio?
Badrot: The main challenge for Centroflora CMS was to establish an acceptable fast-track process that would allow it to transfer products, customers, and all the services associated with an API production site change, and to do all these things concurrently. Centroflora CMS set up the proper infrastructure and transferred manufacturing know-how from BI in record time. We have also taken over more than 130 customer relationships worldwide. This relatively smooth transition provided the basis for continuity of market supply of all the essential-medicine APIs involved in the transaction.
Centroflora CMS’ project management team worked to transfer the products in a methodical way, based on documentation provided by BI. By soliciting limited input from BI’s technical team and by relying mainly on existing documentation, we shielded experts at BI from the substantial resource commitments that are typical for technical transfers.
On the receiving end, a CMO with a wide range of chemical engineering and regulatory experience worked out innovative manufacturing solutions and allowed the project to be completed in only 10 months from start to finish.
Sustainable harvestingPharmTech: Can you discuss how you worked to secure the supply of the API, pilocarpine?
Badrot: CMS, through its partner Centroflora Brazil, secured the vital market supply access route for pilocarpine, an important API used in the treatment of glaucoma and dry mouth disease. This success was based on the cooperation of many stakeholders within the framework of Centroflora’s program called 'Partnerships for a Better World.' Sponsors of this program also included BI and the German government institution 'Gesellschaft für Internationale Zusammenarbeit' (GIZ).
The partnership helps indigenous people in Brazil harvest Jaborandi (the leaf containing pilocarpine API) in a sustainable way. The project uses fair-trade principles and ensures a stable source of income for approximately 1000 indigenous families who live in the Brazilian rainforest. The partnership has demonstrated that big and small companies can cooperate successfully to achieve a common goal-supplying patients with APIs in the most effective way while ensuring that all stakeholders remain committed and engaged.
PharmTech: What are your plans for expanding this program?
Badrot: First, we are interested in sharing the 'Partnerships for a Better World' program with other companies that harvest natural products. Second, integrating other phyto-derived APIs into the program is a strategic objective to help grow a biodiverse API portfolio, which, in turn, should pave the way to find and develop new, sustainable pharmaceutical products.
Other organizations have recognized the potential shown by this business model. In 2015, the Union for Ethical Biotrade, a non-profit organization dedicated to promoting sustainable development and biodiversity, granted approval to Centroflora. Group members commit to sustainable sourcing practices and are required to undergo periodic audits.
The Brazilian government recognized us for both environmental and social efforts. The National Confederation of Industry in Brazil named Centroflora’s pilocarpine harvesting program one of the country’s 10 most sustainable business practices. The Bank of Brazil also recognized the firm for its work to improve conditions for farmers in the northern forest region of the country.
We look at the pilocarpine success story as the way forward for combining bio-based API business with 'fair trade' concepts around harvesting. Ideally, other pharmaceutical companies will be inspired to follow suit. 'Partnerships for a Better World' is an ecological and socially responsible approach to harvesting botanicals. It secures the ability to bring patients around the world a portfolio of trusted, well-established, and vital medicines in a sustainable and responsible way. The program, together with our large investments in API manufacturing with an FDA-approved factory in Brazil, provides the elements needed to attract new phyto API businesses to Brazil.
"Partnership Strategies in Outsourcing"
Supplement to Pharmaceutical Technology Vol. 40, No. 1
When referring to this article, please cite it as J. Markarian, "Success Story: Transferring a Phytochemical API Portfolio," in “Partnership Strategies in Outsourcing” supplement to Pharmaceutical Technology 40 (1) 2016.