July 22, 2021 PAO-07-21-CL-07
Key to Avara’s ability to work as a true partner to their clients is the company’s ability to rapidly respond to changing client requirements, predict future needs, and proactively innovate and invest so that it will be prepared with the necessary capabilities and capacity when those needs manifest. Pharma’s Almanac Editor-in-Chief David Alvaro met with six members of the Avara team spanning their Aiken (South Carolina), Arecibo (Puerto Rico), Liscate (Italy), and Norman (Oklahoma) sites to discuss how all Avara teams continue to innovate their capabilities, technology, and operations to maintain a focus on their clients’ needs, today and into the future.
Collaboration within Avara is as important as collaboration with clients because information sharing across the Avara network contributes to innovation and client relationship development. Each facility is differentiated in our network with specific areas of excellence — Avara Arecibo, for example, is approved as a U.S. DEA Schedule II–V site for controlled substances, which is fairly unusual in Puerto Rico. In addition, we have the capacity to work with highly potent compounds and solvent processes. We have also recently invested in new technologies, from blending to encapsulation, tablet-within-a-tablet compression, coating with water or solvents, spray granulation, spray drying, and high-speed bottling.
Additionally, because clients today require a lot more flexibility and adaptability from their CMOs, we provide many potential options, clearly emphasizing the pros and cons of each to help them make informed decisions. We use the U.S. FDA’s risk-assessment approach and document the language agreed upon with the clients, so we always remain in sync with them. We believe that complete alignment is essential to be a true partner.
Maintaining transparent conversations allows us to comprehensively understand our clients’ needs and build strong, long-lasting relationships with them. To gain their trust as a partner means truly understanding the client and their broader strategy beyond a given product and being flexible to their needs. That understanding and flexibility is essential for companies transitioning from in-house production to outsourcing, which we have seen in higher demand in recent years. These companies are handing over their products/projects for the first time and need complete reassurance that they will be taken care of and receive the proper level of attention from day one. Avara is the right size to provide this level of service to many different clients and to accommodate specific client requests, such as data mining, statistical analysis, and trending.
In order to help facilitate this type of relationship-building, Avara Norman has continued to invest in processing technologies in support of our clients. We have expanded our capabilities for manufacturing under moderate containment conditions, including high-shear granulation, fluid granulation, drying, and transfer. We have also significantly expanded our spray-drying capabilities and have additional improvements and upgrades planned for the remainder of 2021.
The culture on the manufacturing floor is not merely based around making a batch for a client but on efficiently producing the highest-quality product possible to change people’s lives.
At Avara Aiken, we apply the same level of commitment, effort, and time into meeting the needs of each client, regardless of the size of the company or the volume of our business together. In collaboration with Business Development, the Client Relationship Lead (CRL) is introduced to the client even before a request for proposal is submitted. The CRL then remains the facility’s point of contact through development of the relationship, execution of technical transfer, and all the way through commercial supply. During the COVID-19 pandemic, we had many opportunities to observe the efficacy of this process through frequent and clear communications and working with our clients to manage any situations that arose together.
Avara Aiken also offers specialty capabilities to meet a wide variety of client needs, including large-volume manufacturing equipment and high-speed packaging lines to support highly customized configurations for OTC consumer health products. We are able to support products with niche challenges like chewable tablet requirements, and are in the process of bringing a new large-volume blending area online. In addition, we have extensive experience supporting Rx-to-OTC product switches and can provide detailed guidance to clients, particularly those undergoing that transition for the first time. These efforts and others aim to improve and supplement our existing capabilities and streamline our operations to eliminate inefficiencies.
At Avara Norman, the client is a key focus, and we demonstrate that through our transparency and communication. We strive to keep our operations dynamic and innovative to ensure that we have the flexibility needed to meet clients’ exact needs. We continue to innovate in areas across our facility, such as investing in advanced spray-drying technologies and improving on our release and sampling strategies and processes in order to flex in the right directions to help the client and, ultimately, the patient. Additionally, Avara Norman is uniquely positioned to help our OSD clients streamline their operations from tableting or encapsulation through secondary packaging with serialization and aggregation for product tracking. This allows clients to optimize their supply chains and minimize the time it takes to go from product manufacturing to delivery to the patient.
Overall, the driving factor for Avara Norman is our commitment to the client, never losing sight of the fact that we’re working together toward the same, ultimate goal. This involves taking great care of our clients’ products as if they were our own. As such, the culture on the manufacturing floor is not merely based around making a batch for a client but on efficiently producing the highest-quality product possible to change people’s lives. Our team strives to ensure that everything is performed correctly to do what’s right for our clients and patients.
The keyword is collaboration, which is facilitated by open communication channels and the development of service agreements with our clients that ensure clear and flexible solutions.
The COVID-19 pandemic made it very clear how important flexibility is today, and Avara Arecibo was able to respond. We rapidly built our capability to host visits and meetings remotely, which has opened new ways of doing business. I believe that the pandemic has also taught us how fundamental face-to-face interactions are in building client relationships. We have learned during the pandemic that we can continue our business and minimize risk using digital technologies, but we are excited to resume some in-person interactions.
To further support our clients during this unprecedented period, the Arecibo site is also relaunching our operational excellence program in a form that considers the end-to-end supply chain and includes value-stream mapping to evaluate potential solutions for our clients. It will be integrated into different dimensions to include our operating systems, our standardized process, our culture, and our management infrastructure to ensure that it will not only achieve optimized delivery but also serve as a sustainable, continuous improvement program that we can leverage for our clients.
At Avara, we need to stay on top of innovation, because the expectation is that we will always be fast, flexible, reactive, and proactive, regardless of the challenges we encounter.
At Avara, we need to stay on top of innovation, because the expectation is that we will always be fast, flexible, reactive, and proactive, regardless of the challenges we encounter. It is easy to think about innovation in the operational areas, but innovation must continually take place at all levels across the organization to meet our clients’ evolving needs. For instance, during the COVID-19 pandemic, we developed an in-house tool to better manage and track tasks at all levels and embraced new technologies, such as video conferencing during batch validation.
In the injectables space, we are constantly challenged to meet the growing fill/finish demand for novel medicines and a wide range of packaging options from markets across the world — the United States and Europe, of course, but increasingly Russia, China, and Latin America. The greatest demand is for liquid and lyophilized vials, particularly for DNA-, mRNA- and viral vector–based therapies. The fill/finish process for viral vectors is analogous to conventional biologics but with stringent cold-chain management requirements. For mRNA products embedded in liposomes, however, traditional filling lines are not suitable.
We expect mRNA/DNA and viral vector/gene therapy products to become more prevalent in the future, so flexible lines that can handle fill/finish of both conventional biologic drugs and vaccines and those based on these evolving genetic technologies are critical. Avara is looking toward building capability around managing nucleic acids and other innovative biotechnological compounds, including liposome filling.
Along with several large multinational companies, Avara also currently supports mid-sized companies that appreciate the attention and care we provide to them. Looking forward, we plan to enhance our development and clinical capacity, so as to support small companies that are actively developing new drugs and require a fill/finish partner to support them from the beginning of their projects through commercialization. All our investments are driven by the desire to expand to meet our clients’ needs, not only today, but in the future.
Rafael Defendini has worked in the pharmaceutical industry for over 17 years. His areas of expertise include project management, product transfers and improvements, and department management for production and technical services. As Director of Technical Operations for Avara Arecibo, his current focus is on managing technical support for commercial operations, including technology transfers and system validations.