Regardless of headlines in the news touting aggressive fall/winter target dates, vaccines and the accompanying pharmaceutical supply chain are not ready to deliver in mere weeks.
There are some truly amazing efforts around manufacturing COVID-19 testing, treatments, and PPE. Plants have switched gears in weeks or months, some scaling from the thousands to millions of parts per week.
But as a former engineer at a pharmaceutical plant, I can say that manufacturing changes on this scale for biopharma products tend not to happen so quickly, even in unprecedented times.
While packaging suppliers make strides, the U.S. needs work in domestic production of small parts like vials and stoppers for hundreds of millions of people. Beyond packaging and logistics (what our publication focuses on), an effective vaccine candidate— and thus manufacturing and storage conditions—have not been selected or scaled up.
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Traceability and temperature control solutions are needed, as well as education for healthcare providers on what is legitimate product. Waste streams will need securing to ensure that used packaging isn’t collected and reused by bad actors, some of whom could be acting from within the industry when opportunity presents itself.
Naturally, some members of the public are concerned about political pressure affecting the development process. FDA officials have come out with statements (including this one) that they are following the science, and that they "must navigate adeptly while maintaining our independence to ensure the best possible outcomes for public health." Last month, nine vaccine makers made a public pledge not to seek approval without extensive safety and effectiveness data.
As the industry readies itself, automation will play a critical role in meeting public health needs. With this in mind, our Sep/Oct issue will bring you several stories about automation, remote services, waste reduction in the plant, and more.
