Outsourcing-Pharma recently spoke to Dago Caceres, global strategy manager for excipient specialist IFF Pharma Solutions, about the problems faced by drug development and manufacturing professionals, and solutions that might help alleviate some of the headaches.
OSP: It’s been an interesting year for drug development and formulation. Could you please provide your perspective on what the key challenges and developments have been, particularly regarding excipient advancements?
DC: The excipient industry is continuously challenged by the complexities involved in getting novel excipients approved – since there is no viable regulatory pathway for new excipients today. Luckily, steps are being made in the right direction. For example, the Center for Drug Evaluation and Research (CDER) recently launched an excipient review pilot program, which will enable faster approval. IFF is encouraged by programs that help accelerate and respond to customer needs, helping to unlock the benefits of novel excipients more broadly.
At the same time, the industry struggles with approving and commercializing new excipients within a shorter timeframe. Typically, a new excipient can take anywhere from two to 10 years to develop. Then, they must go through preclinical and clinical phases, along with the drug candidate. If these phases are successful – and adopted by the industry – it can take several more years to reach maturity. To drive advancement and innovation for excipients, close collaboration with industry, academia, and key stakeholders is required.
OSP: Please provide a brief overview of the contributions IFF has made to the field—feel free to mention specific products or general areas where your team has made strides.
DC: At IFF, we continue to innovate with our excipients in various applications. With small molecules – as orphan indications become more prevalent and pharma customers seek specific performance – there is a need for more customized solutions that meet customers’ quality and functionality requirements. Given our strong competencies and expertise in polymer science and design, this area is a natural fit.
With large molecules, given the fast-growing nature of this segment, the tendency has been to use existing, approved excipients from traditional pharma that (partially) provide the functionality required by customers. We see room to expand innovation in this space, by designing polymers for specific bioprocessing needs.
OSP: What do you see as the emerging and future challenges facing drug formulators, and how this might affect excipient development and manufacturing?
DC: The digitalization of operational processes is an emerging trend across all industries. In pharma, the expansion of advanced analytics, predictive modeling and other techniques to improve the quality and consistency of end-products will continue to increase rapidly.
As such, stakeholders across the supply chain, especially excipient suppliers, must have a thorough understanding of their products’ functionality-related characteristics and how they can affect the final dosage form. Using this knowledge, they can implement digitalization strategies to ensure consistency in their products and offerings.
OSP: Specifically, how might COVID-19 impact excipients? Feel free to talk about COVID-19 treatment discovery, design, and manufacturing; as well as how the pandemic might impact the supply chain and other aspects.
DC: COVID-19 has tested supply chains across all industries and geographies, like never before. For pharma, the situation is even more critical, since we’re part of a chain that develops life-saving medicines – so, there is limited room for error.
Therefore, it is paramount that we ensure every step of our supply chain is robust and de-risked. From the reliability of raw material supply to delivering products to customers on time, every step is carefully assessed to improve our reliability as an industry supplier.
With regard to COVID-19 treatment, IFF must ensure that we are able to respond quickly to customer needs. COVID-19 showed us that we can move swiftly, when needed, in approving and manufacturing critical treatments. As a leading excipient supplier, we are also committed to doing our part to support the industry during uncertain and challenging times. Our business continuity plans have been analyzed and improved upon over time to ensure reliability, delivering the right solutions when and where needed.
OSP: Anything to add?
DC: Certainly, the last few years have taught us that resiliency and agility are critical attributes to being part of the pharmaceutical industry. IFF (home of Avicel, METHOCEL, and other recognizable excipients) is extremely committed to our pharmaceutical customers and to helping them feel confident in the stability, consistency, and dependability of our products so they can continue doing what they do best.