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www.biopharminternational.com May 2022 eBook BioPharm International 17 approach that accounts for multiple stages of a far more complex commer- cial manufacturing strategy—one that may need to factor in parameters from formulation all the way to packaging, fulfillment, and testing. INCORPORATE ENVIRONMENTAL STEWARDSHIP With the global threat of climate change weighing heavily on public and private organizations, sustainability is rapidly reshaping the competitive vision for the world's top industries. That includes the pharmaceutical sector, which contrib- utes a large share of the planet's emission intensity, higher even than carmakers (4). Environmental initiatives can inf lu- ence a company's launch of a new delivery device in several ways, from limiting the use of certain raw materials such as traditional plastics to working with production partners that embrace alternative energy to power their opera- tions. Drug developers are increasingly building "green" goals into their new product profiles, through product attri- butes like multi-use delivery or min- imized disposables—demands that manufacturers must then address in their production requirements. W h i le t hese ne w t rends a ren't unique to the market for injectable medications, they can further raise the bar for organizations assessing the best combination of characteristics to help their product stand out in a crowded and increasingly eco-conscious mar- ket. But as scientif ic innovation and environmental stewardship increasingly align across the industry, proactively planning for a planet-friendly supply chain will invariably pay off in the short- and long-term. 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 organizations (CDMOs) and other part- nerships as part of their fill/finish com- mercialization plans. However, with many players in the competitive CDMO market—all of them eager to scoop up new business— biopharmaceutical companies are being increasingly scrutinous in their vendor assessment. Factors that have become most important in partner selection include those inherent in a traditional parenteral therapy, with some critical additions. This unique launch requires expertise in not only conventional fill/ finish processes, but also device assembly and secondary packaging. Experience comes high on the list as well, with a spe- cial emphasis on a vendor's understand- ing of how market-to-market patient needs will inf luence device launch. Finding an organization well-versed in international regulation for both drugs and delivery devices will also serve com- panies as they navigate the dual require- ments 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 consolidate 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 deliv- ery systems are set to shape the evolu- tion of patient care in a wide range of therapeutic areas. As drug developers respond, steering more and more com- mercial roadmaps toward pens, autoin- jectors, 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, planning, and foresight for any drug developer—is one that smart organizations can readily prepare for by focusing on these five important steps. By committing time and resources to these considerations, they can not only mitigate many potential challenges but also position themselves and their prod- ucts to capture some of the most valu- able opportunities in our dynamic and fast-growing market. REFERENCES 1. Global Data Sales Analytics, May 17, 2021. 2. CFR Title 21, FDA.gov, Accessed January 11, 2022. 3. EMA, Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect 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). BP Partnerships for Outsourcing Development Biopharmaceutical companies are being increasingly scrutinous in their vendor assessment. With a combination product launch, a CDMO's breadth of expertise matters.