Pharmaceutical Technology - May 2021

Pharmaceutical Technology - Biologics and Sterile Drug Manufacturing - May 2021

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54 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Operations B low-fill-seal (BFS) technology is an aseptic filling process that enables a single machine to perform a continuous sequence of automated operations to mold plastic con- tainers out of molten resin, fill the containers with sterile liquid, then cool and seal them. These steps are performed in a con- trolled sterile, ISO-5 environment with no human intervention dur- ing the filling process, reducing the potential for contamination (1). One study notes that BFS "has emerged as a highly acceptable method for aseptic packaging of liquid pharmaceutical and healthcare products [because it] … provides flexibility in container design, high product output, low operational costs, and assurance of product sterility" (2). BFS is used for over-the-counter products, prescription medicines, and more than 50 injectable products. For example, the Rotarix vac- cine is marketed in Australia in BFS oral unit dose containers. Stud- ies using BFS technology have been conducted for several vaccines including a nasal-administered inf luenza vaccine (3). Global demand for prefilled syringes (PFS) continues to increase and is expected to double from 2017 to 2027 (4). In March 2020, the US Department of Health and Human Services announced a public- private partnership, the Rapid Aseptic Packaging of Injectable Drugs, an initiative designed to enable the Strategic National Stockpile to quickly produce hundreds of millions of prefilled syringes in re- sponse to a public health emergency (5). These developments, along with academic studies and ongoing pharmaceutical industry experience, suggest that this technology could provide a safe and efficacious method to deliver more inject- able drug products including generic drugs and additional vaccines in a prefilled syringe format. Reducing Packaging Costs for Prefilled Syringes Beth Totin and Marcus Webb Blow-fill-seal technology presents an economical option for single-unit dose delivery of vaccines. Factors including drug formulation, material compatibility, extractables and leachables, sterilization, and regulatory approval must be considered. Beth Totin is chief commercial officer, and Marcus Webb is director of communications, both with ApiJect Systems, Corp. ALEXNGM - STOCK.ADOBE.COM

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