Outsourcing
Left: Given regulatory regimes differ across borders, it can be beneficial to manufacture drugs in the country where they’ll eventually be sold.
Below: BioNtech and Pfizer have pumped out four billion vaccine doses within the past year alone.
radioactive drugs, and now consults from his home in New England. To put it another way, Glajch has seen it all, and is keen to reflect on just how vital CDMOs have been across his long career. In his final pre-consulting job, for instance, Glajch recalls that his team at Momenta Pharmaceuticals “essentially did no manufacturing at all” and instead outsourced production wholesale to China. Glajch’s story isn’t unique. According to one recent
study, the pharma CDMO market is expected to grow at a CAGR of over 7% between 2020 and 2027, with growth predictably marked across East Asia. As a report by Research and Markets notes, China’s CDMO market will soon enjoy compound annual growth approaching 20%, with gene therapy and other ground-breaking fields particularly buoyant. Emily Thompson, US director for new process technology at DPS Group, says the complexity of many new therapies likely begins to explain these remarkable numbers. “The design, construction, and qualification of a new pharmaceutical manufacturing facility can be a multi-year process that requires a large upfront capital expenditure,” she says. “For immediate manufacturing needs, companies have come to rely on CDMOs to bridge the gap in their manufacturing capacity.” That’s doubly true, Thompson continues, given how unpredictable bringing a new drug to market can be. With specialisation being the order of the day, it makes sense to lean on experts in a specific field, whether that’s making plasmids or filling syringes. Glajch agrees, noting that he hired CDMOs while at DuPont to make lyophilised (freeze-dried) products at a time when the technology was still fairly unknown. There are other advantages to CDMOs too. Given regulatory regimes differ across borders, it can be beneficial to manufacture drugs in the country within which they’ll eventually be sold. And in an emergency, external partners can be conscripted to
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
“The design, construction, and qualification of a new pharmaceutical manufacturing facility can be a multi-year process that requires a large upfront capital expenditure.”
Emily Thompson
quickly scale up production. That last point, at any rate, has been vividly borne out since 2020. Once again, Pfizer offers a good case study here. As the American leviathan notes, it has partnered with BioNtech to recruit some 20 CDMOs for Covid-19 vaccine production. Scattered across four continents, these firms are helping to pump out four billion doses this year alone. Bigger contractors, for their part, are also supporting the anti-Covid fight in other ways. Catalent, a Boston-based CDMO, is researching antivirals and diagnostics – as well as having developed capacity to make a billion vaccine doses by the end of last year.
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