Issue link: https://www.e-digitaleditions.com/i/1373953
Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 53 The fill volume for ophthalmics is typically in the range of 100 µL to 200 µL. The risk of reject- ing containers due to underfill or overfill can be eliminated by using single transport of contain- ers through the system, with each container being weighed before and after filling. If the filling line transports through vial-by-vial or syringe-by- syringe on the same machine, every container can be weighed using a dual tare/gross-system. Therefore, the volume in each container can be cal- culated and a feedback loop can be used to correct the pump speed automatically, which results in pre- cise and accurate filling, reducing potential wastage. Overstretched capacity PharmTech: Demand for services, such as fill/fin- ish, seems to be greater than available capacity at the moment, how is this impacting fill/finish operations? Kehl (swissf illon): It is widely recognized that demand for fill/finish services greatly exceeds current supply, and more facilities are being built, mainly to provide high-speed filling lines for COVID-19 vaccines. As an example, the supply of prefilled syringes is predicted to increase from around 2.5 billion today to around 4 billion in the coming years, and vaccine production will continue to drive the business for many years to come. In addition, the need for fill/finish ser- vices will expand due to the increasing use of injectables to treat diabetes, cancer, and other chronic conditions. Grow th in the ophtha lmics market will be driven by the rapidly aging global population, ocular diseases associated with diabetes, unmet clinical needs, and economic growth resulting in increased demand in developing countries, par- ticularly in Asia. The R&D pipeline for drugs to treat retinal disorders is also very strong and includes new classes of therapeutic agents. It is likely that the dominance of blockbuster prod- ucts will diminish as patents expire over the next few years, and innovative products will be devel- oped by biopharma companies. PharmTech: Is industry approaching a capacity crunch for fill/finish? Kehl (swissfillon): For ophthalmics fill/finish, we are looking at small to mid-size systems, which have different requirements to high-speed lines, and the lead time for this t y pe of f illing ma- chine has increased from one and a half years before the pandemic to around two and a half to three years. Our filling line is equipped with single-use systems, the only way to guarantee lower line loss and no cross-contamination. Production ca- pacity is determined not only by the machine's availability, but by supplies of components such as vials, filters, and tubing, which now have lead times of around 55 to 70 weeks. Fortunately, through established partnerships, it is possible to get some components early, but this is a criti- cal issue. Some of our existing customers are facing similar problems, which impacts produc- tion; therefore, it is critical for customers to plan ahead in order to get their products to the market in the shortest possible time. References 1. Markets and Markets, Fill Finish Manufacturing Market by Prod- uct—Consumables (Prefilled Syringes [Glass, Plastic], Vial), Instru- ments (Systems [Standalone, Integrated], Machine Type [Auto- mated, Manual])—End User (CMO, Biopharmaceutical Company)—Global Forecast to 2025, Market Research Report (May 2020). 2. R.N. Khurana, L.K. Chang, and T.C. Porco, JAMA Ophthalmol., 135 (7) 800–803 (2017). 3. J.H. Yu, et al., Am. J. Ophthalmol. Case Rep., 10 (June) 142–144 (2018). PT