Ian Bolland sat down with Web Industries vice president of medical Kevin Young and business development director Claudio Hanna. Web Industries is the domestic COVID-19 test manufacturing partner of numerous U.S. companies.
Young began by explaining that the company’s investment in lateral flow immunology in recent years positioned it to be able to quickly pivot to producing Coronavirus tests. Web is one of the few medical contract manufacturing organisations (CMOs) in the U.S. equipped to meet all the requirements necessary to produce the COVID-19 tests.
He said: “Ramping up our plant to produce, on average, over 1 million tests per week, with a goal of reaching 2 million tests per week by the end of the year, has been a major shift in our priorities.”
Young identified three major challenges necessary to switch production quickly: having systems in place so that the transition could be handled from both equipment and enterprise resource planning perspectives; targeting and hiring the right people from outside the company or sourcing the right employee-owners from within the company; and being able to rigorously document every development process along the way.
These were not the only hurdles that had to be overcome. Young also outlined the availability of components, the stability of the supply chain and the status of government subsidies to support test manufacturing were also concerns during production ramp-up.
“In many cases, the individual components, especially crucial flexible materials, are in short supply because a lot of the supply chain had been absorbed by Chinese-produced tests, many of which the FDA has not approved for use in the U.S.
“We’ve had to leverage people throughout our company to locate and secure these items. In many instances, we are turning to our existing customers and suppliers to utilise their capacities to produce these components for use in the tests and testing kits that we are manufacturing.
“Another challenge has been where government funding has been focused. The NIH (National Institutes of Health) was commissioned to develop a process to secure hundreds of millions of domestically-produced tests a month. Early funding priorities focused on test development but did not take into account how much of the domestic medical manufacturing base had been lost over the past few decades.
“With the vast majority of government support being allocated for test development, little thought and almost no funding has gone into answering ‘how do we manufacture these tests within the U.S. once they are FDA approved?’ That’s where companies like Web need support as well. Downward pricing pressures and health care market uncertainties have driven CMOs to be as efficient as possible, with very little slack in their systems.
“Collectively, we know how to scale production to meet the pandemic-driven surge in demand, but the capital requirements are prohibitive without either guaranteed contracts that can be borrowed against or direct investment by government agencies or private foundations. We’ve been reaching out to the NIH, CIMIT, and talking to federal and state officials everywhere that we have a facility to pursue contract guarantees or funding to support expanding our manufacturing capacity to meet the country’s needs.”
According to Hanna, the company has focussed on rapid but efficient production expansion since the beginning of the pandemic.
“As companies developing diagnostics approach us about moving their tests into manufacturing, we carefully evaluate their entire process, from the biochemistry all the way through kit assembly, to determine what production and supply chain infrastructure we would need to reach their desired production levels. How many new manufacturing cells would need to be built out? How much of the process can be automated and what requires human interaction? Where are the likely supply chain weak points and what are our alternatives? Quite a bit of our job has been discovery and coordination to make sure that everything comes together smoothly.
“How do you put together operations that don’t naturally flow into each other? How do you assemble these processes into a manufacturing cell that is cohesive, works as a unit, and can be readily replicated to scale production? Those are some of the areas where our engineers have been highly focussed.”
On top of these challenges, necessary pandemic-driven travel constraints and work from home mandates have made these efforts more difficult than they would be ordinarily. “For example, our manufacturing process utilises equipment manufactured in Spain. Last month we needed to inspect several new machines before taking possession of them, but transatlantic travel restrictions prevented us from flying personnel over from the U.S. Luckily, travel within the EU had been relaxed, and an engineer from our aerospace-focused facility in Stade, Germany, was able to drive to Spain to examine and approve the machines.”
In terms of demand during this period, Hanna added: “We’ve probably spoken to over one hundred different companies that are developing COVID-19 tests. Most of those have great ideas, but many lack the manufacturing, supply chain or regulatory experience to design tests that can be successfully mass-produced. A company can have an innovative new approach to virus detection, but if it utilises sensitive chemistries that cannot be produced in commercial-scale volumes or components that cannot be reliably sourced, the test is not going to be viable in the market. Our product transfer process and design-for-manufacturability expertise guides these companies away from technological dead ends and allows them to focus on developing testing technologies that can meet the needs of a world in crisis. We are fortunate to be in a position to support these companies.”