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56 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Combination Products Supplement in-house capabilities with outside experts As demand continues to grow for patient-friendly therapies, organizations that traditionally focused their operations outside of the delivery device arena will encounter a mix of challenges as they take on the complexities of a combination product launch. To fill blind spots and complement their internal skillsets, these companies are increasingly turning to contract development and manufacturing orga- nizations (CDMOs) and other partnerships as part of their fill/finish commercialization plans. However, with many players in the competi- tive CDMO market—all of them eager to scoop up new business—biopharmaceutical companies are being increasingly scrutinous in their ven- dor assessment. Factors that have become most important in partner selection include those inher- ent in a traditional parenteral therapy, with some critical additions. This unique launch requires expertise in not only conventional fill/finish pro- cesses, but also device assembly and secondary packaging. Experience comes high on the list as well, with a special emphasis on a vendor's under- standing of how market-to-market patient needs will inf luence device launch. Finding an organi- zation well-versed in international regulation for both drugs and delivery devices will also serve companies as they navigate the dual requirements of those technical disciplines. With a combination product launch, a CDMO's breadth of expertise matters, too. A manufacturer who can provide comprehensive support—from fill/finish, to device assembly, to secondary pack- aging—can enable the drug developer to consoli- date contracts, streamline process and service handoffs, and stay focused on core competencies and overarching goals like sustainability. Navigating complexity to achieve success With demand trending upwards for years to come, patient-friendly delivery systems are set to shape the evolution of patient care in a wide range of therapeutic areas. As drug developers respond, steering more and more commercial roadmaps toward pens, autoinjectors, and wearables, the combination product launch will increasingly become a defining step for the market's most successful parenterals. That challenging transition—a test of skill, plan- ning, and foresight for any drug developer—is one that smart organizations can readily prepare for by focusing on these five important steps. By com- mitting time and resources to these considerations, they can not only mitigate many potential chal- lenges but also position themselves and their prod- ucts to capture some of the most valuable oppor- tunities in our dynamic and fast-growing market. References 1. Global Data Sales Analytics, May 17, 2021. 2. CFR Title 21, FDA.gov, Accessed Jan. 11, 2022. 3. EMA, Questions & Answers for Applicants, Marketing Authorisa- tion Holders of Medicinal Products And Notified Bodies With Re- spect to the Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746) (EMA, June 23, 2021). 4. L. Belkhir and A. Elmeligi, J. Clean. Prod., 214:185-194 (2019). PT With demand trending upwards for years to come, patient-friendly delivery systems are set to shape the evolution of patient care in a wide range of therapeutic areas.