Relationship building and the benefit of deepening collaborative business models between excipient manufacturers and pharmaceutical companies in support of formulation development and manufacturing in a quality-by-design (QbD) paradigm and enhancing supply-chain practices was a key takeaway from ExcipientFest Americas, which was held in San Juan, Puerto Rico, this week. ExcipientFest Americas is operated by the Drug, Chemical and Associated Technologies Association (DCAT). ExcipientFest Americas is an exhibition and educational program that addresses technical considerations in excipient selection and formulation development as well as sourcing and supply-chain issues for excipients.
Janeen Skutnik, chair of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) and director of quality and regulatory policy, global regulatory CMC at Pfizer, spoke of the importance of QbD. IPEC-Americas has formed a working committee, the Quality by Design Product Development Committee, to consider issues relating to excipients and QbD. She emphasized that the goal of QbD is to enhance process understanding, which includes understanding the variability of raw materials such as excipients in a specific formulation and manufacturing process. She underscored that QbD involves building robust formulations and processes that can adapt to this variability while maintaining the performance and quality of the pharmaceutical product and does not simply mean creating tighter and tighter specifications for excipients. “QbD does not equal tighter specifications for excipients,” she said, but instead she said that QbD is used to facilitate the understanding of the functionality of an excipient in a given formulation and manufacturing process.
As discussed by Skutnik, enhancing excipient user–supplier collaboration is an important aspect of building the shared knowledge that is critical to developing the deeper understanding required in QbD. This symbiotic relationship between excipient user and supplier not only produces technical benefits, but is also at the center of a productive business relationship, a point emphasized by Alex Pena, purchasing manager at Schering-Plough, who spoke on business and operational excellence in materials supply. He discussed the importance of building a “win-win” relationship in which both suppliers and the pharmaceutical customer benefit. He emphasized the value in building collaborative business models to meet the increasing complexity of a global pharmaceutical supply chain.
What these issues—QbD and optimizing supply-chain practices—tell us is that the relationship between excipient suppliers and pharmaceutical-company users will continue to evolve to meet these ongoing challenges.