CKH_issue01_2025_July

61 CHEMICALS KNOWLEDGE HUB Issue 1 / July 2025 CMOs extends into commercial gene therapy production through its partnership with Sarepta Therapeutics. “Once you pass that $100 million threshold, feasibility and viability need to catch up,” said Lai. “How do you launch products in five countries with different regulatory environments? How do you ensure the supply chain and quality systems are aligned? That’s where the right CMO can make or break a brand.” Smaller batch flexibility Alongside the global giants, smaller, fast-growing brands are also having their say when it comes to CMO expectations, particularly when it comes to batch flexibility. Market fragmentation has made low-volume, high-mix production a strategic musthave. “There’s no such thing as a one-size-fits-all consumer anymore,” said Adamek. “Everybody’s different - even within a single country. So the product core might be designed for the mass market, but there must be a good stretch of legs to fulfil the needs of individual or local markets.” CMOs once focused on volume are now adopting modular lines and flexible batch runs to support smaller volumes and faster turnarounds. A startup supported by EIT Food recently chose a US-based CMO after facing ingredient import restrictions. “They had no choice but to find a local manufacturer,” Adamek recalled. “It was like having two different operations for European and American markets.” This scenario is now a common theme and those CMOs offering regional capacity are well-positioned to benefit. Transparency and traceability However, as geographic complexity grows, so too does the need for transparency. For brands managing multiple markets, trust must be earned through clear data, traceability, and shared accountability. “Global gives you scalability. Local gives you trust. And people buy what they believe aligns with their values,” said Adamek. In the age of AI, clients demand not just outcomes but explainability. CMOs are increasingly expected to provide real-time traceability tools, batch-level data, and even consumer-facing QR codes linking to sourcing and sustainability credentials. Steve Horvath, a Principal Investigator at Altos Labs, described one vision for the future that uses intuitive labelling systems powered by AI and biometric data. “Imagine a food label that says, ‘If you eat this, there’s a red alert: it increases your risk of type 2 diabetes.’ That’s where we’re heading, and CMOs need to be ready.” Sustainable or localized manufacturing? Personalised insight demands supply chain transparency, including how and where products are made, with an increasing focus on sustainable, local manufacturing. “A lot of startups want to show off in other markets,” said Adamek. “But they’re realising they need local operations—local ingredients, local packaging, local compliance. It’s a supply chain challenge, but also a brand trust issue.” CMOs are sourcing locally, cutting emissions, and offering digital sustainability reporting. Those with geographically diverse facilities, renewable energy initiatives, or upcycled ingredient partnerships are gaining an edge in competitive bids. Meanwhile, venture capitalists like Giancarlo Addario are advising portfolio brands to partner with CMOs that can help them scale without compromising authenticity. “You need to design your international strategy—how you define your product development and branding roadmap,” he said. “The right manufacturing partner is central to that.” WILL CHU Editorial team CHEMICALS KNOWLEDGE HUB

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