BioPharm April eBook: Outsourcing Resources 2019

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Page 20 of 28 April 2019 BioPharm International eBook 21 Outsourcing Resources Manufacturing often limited material safety data available on the clinical batch size product, which can make it dif- ficult to establish a cleaning proto- col, thereby driving up costs. Many larger customers do not want their product on a line with clinical batches, and this leads CMOs to favor established products. Finally, the smaller targeted patient popu- lations per indication and the high efficacy of biologicals have a direct ef fec t on commercial demand, which ca nnot be compa red to standard blockbusters: CMOs have to find a way to adapt their fill/fin- ish technologies and business mod- els to provide more flexibility for their clients. This situation is not simple and requires finding the right balance between the parties' different interests. Both have the need to find a win-win solution, which is the essence of a fruitful and long-standing partnership. There has been an increased demand for clinical size batches of lyophilized biologic products within the CMO sector. In addition to the usual concerns about process— lyophilization cycle parameters, for example—there is often an issue of how to adequately clean the line and equipment between each batch. Within the sterile manufacturing sector, for example, there has been a general trend to transfer sterile prod- ucts to CMOs. This is largely driven by the fact that large bio/pharma- ceutical companies want to trans- fer their older sterile products out and use that valuable manufactur- ing space for newer biologic prod- ucts. The cost of maintaing sterile fill/finish facilities keeps increasing; so do the challenges of complying with more demanding regulatory scrutiny. Furthermore, the pressure around drug pricing has never been higher. These factors are pushing companies to strategically harmo- nize their manufacturing capabili- ties. In this case, outsourcing a larger portion of the pipeline to CMOs can provide more flexibility and access to additional technology resources and capacity. A naly tical as well as chemis- try, manufacturing, and control (CMC) ser v ices are an integ ral part of the drug manufacturing process, even more so in sterile and topical product manufactur- ing. An ability to provide these ser v ices on-site enhances qual- ity, allows faster response times, reduces produc t rejec t ion, a nd enhances data integrity. NAVIGATING REGULATORY REQUIREMENTS BioPharm: What should be in the CMO's arsenal when there are sig- nificant regulatory and legislative changes afoot? D a n z i (L e g a c y Ph a r m a c e u t i c a l s): Being aware of, and ahead of, reg- ulatory and legislative changes is an important part of being suc- cessful in the CMO industry. For example, recent changes requir- ing serialization have demanded significant investment in equip- ment and software to support the reg ulator y requirements. CMOs have to be ahead of their clients' d e m a nd s wh i le i mple me nt i n g these complex changes. This is only possible when a CMO has the experience as well as the flex- ibilit y to rapidly adapt to offer these services. A not her e xa mple is t he ba n on animal testing (for toxicit y studies), which has required that CMOs find alternative methods to ensure products comply with these new laws, while also com- plying with existing dossiers and regulatory requirements. DEVELOPING GOOD CMO/SPONSOR RELATIONSHIPS BioPharm: How does a CMO appro- priately manage the customer rela- tionship? Danzi (Legacy Pharmaceuticals): At the end of the day, CMOs are a customer-service business like so many others in other industries. It is important to focus on being a seamless, responsive part of the customers' supply chain. For new customers, CMOs should be able to provide complete product trans- fer technical services to ensure smooth transition and continuity of supply to the market through open, efficient and professional communication during all stages. Essentially, CMOs are an exten- sion of the customer's global sup- ply chain and as a partner, should be easy to reach and talk to on a daily basis. REFERENCES 1. Research and Markets, "Biologics Outsourcing Global Market— Forecast to 2025," Report, August 2017, www.researchandmarkets. com/reports/4375383/biologics- outsourcing-global-market-forecast-to. 2. Results Healthcare, "Pharma & Biotech 2017—Review of Outsourced Manufacturing," Report, January 2017, wp-content/uploads/2017/01/Results- Healthcare_Pharma-Biotech-2017- Review-of-outsourced-manufacturing_ Whitepaper.pdf. BP "… outsourcing a larger portion of the pipeline to CMOs can provide more flexibility and access to additional technology resources and capacity." —Mike Danzi

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