In December, medical technology company and pioneer of the prefilled syringe (BFS), Becton Dickinson (BD), announced plans to invest around US$1.2bn over a four-year period to expand and upgrade manufacturing capacity and technology for PFS, as well as advancing drug delivery systems (ADDS) across its six global manufacturing locations and adding a new manufacturing facility in Europe.
The European facility will be on stream in 2023.
This investment, it said, would also fund capacity expansion, new product innovations, manufacturing technology enhancements and business continuity improvements across its existing network, all designed to maximize supply and reduce risks for pharma companies relying on ready-to-fill syringes for their injectable drugs from complex biologics to vaccines and small molecules.
Eric Borin, worldwide president of BD Pharmaceutical Systems, commented: “Since 2018, BD has added 350 million units of manufacturing capacity for glass barrel pre-fillable syringes, and this new commitment will invest in additional upgrades at all of our pharmaceutical systems manufacturing facilities and across multiple product categories. In addition, this investment positions BD to have the needed surge capacity for increased pre-fillable syringe demand during times of pandemic response or periods of significant growth of new injectable drugs and vaccines.”
‘Next generation’ disposable injectors
ApiJect is looking to make plastic, prefilled injectors to replace multi-dose glass vials. The US company says the disposable injection device can be mass-produced to deliver vaccines and other medications globally.
"This is going to be, we believe, the next generation of safe injections worldwide," ApiJect CEO, Jay Walker, told NPR.
The innovator got approval back in November 2020 from the US International Development Finance Corporation for a US$590m loan to construct a multi-facility campus.
That facility, opening in 2022, should enable the US to more quickly package high volumes of vaccines in the event of a national emergency, beginning with COVID-19, said the firm.
Located in Research Triangle Park, North Carolina, the massive campus will have, at its center, the ApiJect Gigafactory, which is set to be of the world's largest pharmaceutical fill-finish facilities and is expected to hit an annual production capacity of up to 3 billion single-dose prefilled injectors.
The facility is being designed to combine aseptic drug packaging technology with ApiJect's proprietary pen needle-style hubs to rapidly package drugs and vaccines in the company's BFS prefilled injectors. The process uses pharmaceutical-grade plastic resin to create, fill and seal a strip of 12-to-25 drug containers per production line every three seconds, said the company.
The Gigafactory would be able to handle vaccines requiring standard cold storage, as well as those in need of ultra-cold storage.
Nicole Lurie, a strategic adviser at the Coalition for Epidemic Preparedness Innovations who served as the assistant secretary for preparedness and response at the US Department of Health and Human Services, was cautious about such devices, telling NPR that this was untested technology: “What testing has been done to ensure that the materials inside the containers don’t interact with the compounds of various vaccines? They probably need to be tested for each vaccine and especially each vaccine platform.”
COVID-19 vaccination campaigns relying on conventional packaging
All the innovation aside, COVID-19 vaccines are currently being distributed in multi-dose glass vials. Christy Eatmon, senior scientist, pharma services, Thermo Fisher Scientific, explained why:
“Since the demand for COVID-19 vaccines is extremely large, single dose PFS is not an efficient option. The number of doses produced in a single batch is much larger, enabling vaccination of more people. Additionally, the shortage in glass, disposable systems, filters and other materials required for filling drug product means that more doses can be manufactured with lower volumes of these consumables that are in limited supply at the moment.”
In July 2020, BD confirmed that the UK government’s order for 65 million syringes at the time would be “unlikely to be delivered in prefilled syringes due to the accelerated speed with which the vaccination program needs to be rolled out.”
The same month, Pfizer said that it was considering multi-dose vials instead of single use “to allow for more efficient production as they can be filled faster.”
When asked whether the growing recognition of the advantages of prefilled syringes has resulted in a major shift in the marketplace away from the use of multi-dose vials for vaccines, in general, Eatmon said not necessarily so.
“For vaccines like the seasonal flu, where many doses will be given in a short timeline, a multi-dose vial is still the most efficient and economical. However, for vaccines given less frequently or on a smaller scale, PFS may be advantageous due to the ease of use and simplicity of packaging in a single dose,” she told us.
One big advantage of PFS products is that the single dose formulation is preservative-free, she added.