Pharmaceutical companies need CDMO partners that provide solutions at fair value. Fareva has a long history of investing in new technologies with innovators to help our customers achieve their goals, and one recent example is the construction of a new Hastelloy spray-drying unit.
A Spray-Drying Problem
A few years ago, Fareva entered into discussions with an innovator that was single sourced for a highly specialized, spray-dried API quickly moving toward an NDA filing after very positive clinical trials. The sponsor needed to ensure a continuous supply of the API, but being single sourced highlighted a limitation in their supply strategy should volumes grow or unforeseen supply interruptions occur. Due to the unique physical properties of their API, the sponsor believed that there could be campaigning advantages with a Hastelloy spray dryer. Unable to find a suitable existing unit but needing to establish a dual-source supply chain for a key product, the sponsor sought to find a high-quality CDMO willing to oversee the design, construction, and installation of specialized equipment. The sponsor needed to find a partner who would support the project from R&D to submission and to commercial supply.
Establishing a Partnership
The sponsor set out to find a contract service provider that would be willing to work as a true partner in order to develop a second source. Fareva was initially approached as a potential partner because Fareva has years of experience developing and implementing aqueous spray-drying processes, and the sponsor was familiar with our commitment to collaboration and transparency.
Implementation of this project would involve an extension of our capabilities, given that we had not previously performed solvent-based spray drying. Due to the nature of the process, control measures would need to be implemented, and the sponsor required the construction of a special Hastelloy spray dryer.
As such, we understood that the sponsor would investigate and determine whether another provider could offer a better fit in terms of cost and timing. In addition to Fareva, several CDMOs prepared proposals. The sponsor appreciated Fareva’s comprehensive proposal, which not only systematically addressed each program requirement but also provided a win–win payment structure that had a balance of up-front costs and back-end milestone payments. As a family-owned company with a flat management organization, Fareva has the flexibility to offer innovative financial packages with a simplified approval process and a long-term perspective for projects that we feel have significant potential to expand our specialized capabilities. Fareva won the RFP based on our historical experience, the familiarity of the customer with our Valdepharm site and team, our comprehensive approach to addressing the sponsor’s requirements, and the willingness of Fareva to co-invest in the new spray-drying unit.
Despite the complexity of the project, the negotiations took just six months. The sponsor was honest and transparent about the capabilities it could bring to the table, and Fareva was transparent with our costs and capabilities. As a result, within 12 months of the initial sponsor’s request, a contract was completed and the project started. The sponsor found the experience to be straightforward and transparent, with equitable construction of the contract. In this situation, both parties shared the risk and the investment, but also benefited from some guarantees. Construction of this new spray-drying unit was initiated in May 2018 and will be completed in Q1 2020, with qualification and validation expected to be finalized in Q3 2020, followed by commercial production of the sponsor’s approved product.
Finding Collaborative Partners
The need for a Hastelloy spray dryer led to the need for a custom-designed unit. After speaking with several design firms, Fareva selected the company that was most open and transparent about the design and cost and willing to work collaboratively.
Our engineering and technical experts at the Valdepharm site work closely with both the sponsor and the design firm to address details related to the reactor, pump, filter dryer, and other components. More than 100 changes were made to the design over a 5–6 month period before arriving at the final design. The open, collaborative design review process for the spray dryer impacted how the entire suite was designed. The overall result was an optimal spray dryer and operating unit, not only for the sponsor, but as general-use equipment.
Specialized Spray Drying Solution
The new spray-drying unit is located at Fareva’s Valdepharm site, a state-of-the-art facility in Normandy, France approved by global regulatory authorities, including the U.S. FDA, EMA, ANVISA, and others. The site manufactures APIs, including sterile powders, steroids, and controlled substances, as well as sterile injectable drug products.
The system is designed according to cGMP requirements for the handling of both organic and aqueous solutions. It is resistant to corrosive and acidic materials and designed to safely process potent compounds. Processes can be run in air or under nitrogen. With an average capacity of 25 kg/h, depending on the concentration of the solution, batch sizes can range from 100 kg to 1 tonne.
Once spray drying is complete, products can be packaged directly or undergo further processing before packaging, such as secondary drying in a filter dryer and/or milling to achieve the desired particle size/particle size distribution.
The unit is supported by our in-house process development, QA/QC, and microbiological laboratories.
People Make the Difference
Having the facilities, equipment, and capacity to produce APIs, even for APIs that require specialized technologies, such as spray drying, is not sufficient for establishing real differentiation as a CDMO. Having the right people is also essential. Fareva recognizes this critical fact and has sought out individuals that are dedicated to projects, are invested in the customer’s best interest, and value open and transparent communication.
Teams composed of individuals with this level of commitment create, over the length of a project, the highest likelihood for success. All information is known and shared, and the customer is kept up to date in real time about all aspects of the project, including problems that arise. Customers realize that the human element at Fareva contributes substantially to risk mitigation. Our teams are led by a project manager who is the main point of contact throughout the lifetime of the project, and every member of each project team is fully engaged and in communication with the customer.
In addition to the commercial spray-drying unit, Fareva has invested in an R&D-scale spray dryer that will enable our process development experts to efficiently establish the appropriate design space, identify critical process parameters, and develop optimal processes.
Already Attracting Attention
We recognize that taking on this project involves expansion of our technology and capabilities, which carries some risk. Fareva has a history of investing in innovative technologies and a well-established process for performing methodical gap analyses to determine what capabilities and human resources are needed when moving into new technical areas.
Indeed, Fareva has a reputation for being able to successfully develop and implement new technologies for customers. This track record, combined with our open and transparent approach to project management and our permanent staff of experienced chemical engineers, creates a level of comfort for customers familiar with the Valdepharm site and our experience, capabilities, and personnel.
Validation of a second product is expected in Q4 2020. Combined, these two products will account for less than 50% of the capacity and, beginning in the second half of 2020, we will be able to take on additional projects.
A True Solution Provider
In the case of the spray-drying unit, we listened to our customer and worked together with their experts to develop an industry-leading technical capability in spray drying that can support a wide range of products, including corrosive materials.
The investment in the new spray-drying unit is just one example of Fareva’s willingness to collaborate with customers to solve their GMP manufacturing challenges. Whether the solution involves an investment in new technology, the addition of R&D capabilities, the modification of existing equipment, or some other activity, we have the desire and ability to act as a true solution provider for our customers. We are capable and willing to support customer projects at a fair value, serving as a true partner.