Issue link: https://www.e-digitaleditions.com/i/1248960
22 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m that are in place in the United States (2) and Europe (3). "These regulations are key with respect to preventing transmission of blood-borne viruses such as HIV and hepatitis C," he notes. "The regulations state that employers are responsible for the safety of their staff whether in an acute hospital setting, an alternate site, or domestic home environment. Therefore, designs that incorporate automatic or passive deployment of the needle shielding during use are seen as advanta- geous as no additional steps are required by the user as part of the routine injection procedure." Testing for safety "Injection devices that contain drugs and biolog- ics are known as combination products and have a specific regulatory pathway via the FDA for the US market," explains I'ons. "In the European Union (EU) no such category exists at present, although there is ongoing work to create one, so drug–device combination products are still approved as medici- nal products." For combination products, it is necessary for com- panies to ensure all necessary development and testing are performed on drug delivery devices, as would be the case for any medical device, to ensure safety. "Test- ing is required even though drug delivery devices are not subject to the usual regulatory approvals, such as 510(k) in the US market," confirms I'ons. Components of both the syringe and plunger should be tested for any extractables and leachables, notes Sacha. "The materials are often complex mix- tures that have the potential to interact with certain components in the injectable formulation," he says. Additionally, once the components of the device have been filled, then break force or glide force stud- ies can be conducted, which allow companies to ensure that the prefilled syringe functions correctly. These studies are also performed at certain time points during stability testing, Sacha remarks. Testing, such as for biocompatibility, aging studies, and transit testing, along with normal validation and verification sequences, forms part of the routine devel- opment process for combination products, I'ons contin- ues. "The goal is always to demonstrate that the final combination product is safe for the end user," he says. Emerging solutions and trends As a result of challenges during formulation develop- ment of biologics or biosimilars, many companies are considering and developing higher volume prefilled syringes, asserts I'ons. "Therefore, the industry is seeing a projected increase in demand for prefilled syringes with a volume greater than 1 mL (which is the common volume used), typically to a volume of 2.25 mL," he notes. "Consequently, prefilled deliv- ery devices for 2.25 mL primary containers are now starting to emerge on the market, most of which are also incorporating needle stick injury safety features." Moreover, with the upswing in trend for increased volumes, industry is also witnessing growing interest in wearable drug delivery devices. "These wearable devices can potentially accommodate volumes in ex- cess of 10 mL," says I'ons. Other solutions in development, and also some that are already on the market, are silicone-free syringes Manufacturing "Using less silicone on needles can prevent, or at least reduce, the amount of silicone that is deposited in the injection site." —Gregory Sacha, Baxter BioPharma Solutions