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Move anticipates high-volume Covid-19 vaccine and therapeutics production, amidst other vial-production advances
SiO2 Materials Science—no newcomer to vial/syringe production for vaccines and other drugs—has won a $143-million contract from two federal agencies to expand production of its containers. The company says that it will double its staff of 200 at its Auburn, AL facility, and raise its production to 120 million vials/yr. The money comes from the Biomedical Advanced Research and Development Authority (Barda) and the Defense Dept.’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
SiO2 Materials Science (until last year, SiO2 Medical Products) has developed a multilayer technology for vials and syringes in pharma applications. A container can consist of an outer cyclic-olefin polymer (COP), with a multilayer internal coating of silicon oxide (SiO2—essentially, glass) layer and an organosiloxane layer for pH/chemical resistance. These inner layers are applied via a plasma-enhanced chemical vapor deposition process—similar to how microelectronic chips are manufactured (see photo). The containers are already commercial for, among others, Novartis’ Lucentis product, as well as a malaria vaccine being commercialized by Sanaria, Inc. (The latter product, interestingly, would be shipped under cryogenic conditions.)
According to Lawrence Ganti, chief business officer at SiO2, its vials have the advantages of being essentially inert (no leachables or extractables), and are delivered ready to be filled, whereas conventional borosilicate glass vials need to be cleaned prior to filling. Costs are roughly comparable between the two, he says.
There are other developments in the vial production scramble. Schott Group, the leading producer of borosilicate glass for pharma packaging, issued a position statement in late May, “Answering the hard questions about pharmaceutical packaging supply,” stating that “Short-term demand for pharmaceutical packaging can be met if industry focuses on ramp-up and prioritization.” To that end, it is already expanding its production of borosilicate glass tubing by 40,000 tons/yr, “enough raw material to produce an extra 6.8 billion standard vials,” and is expanding its converting lines (necessary to produce pharma-grade containers) with a $1-billion investment.
Meanwhile, in the haphazard arena of White House response to the pandemic, there was an earlier announcement that a company, ApiJect, would lead a “consortium” to develop a high-volume vaccine container based on plastics and blow-fill-seal technology. ApiJect (which had been founded three years earlier to develop this technology for developing-world public health practices) has received funding support from the Defense Dept. to build capacity for a supply of 100 million prefilled syringes by year-end, and up to 330 million units/month by 2022.
The ApiJect syringe is a single-use, single-dose device; vials can be single-dose or multiple-dose (provided that the syringe used to extract the dose is not itself reused from patient to patient). SiO2's Ganti says that the consensus among vaccine companies addressing the pandemic is to go with a 10-ml multi-dose vial, such that a vial production of 120 million/yr translates into over 1 billion dosages; but the exact volume of dosages remains to be worked out.