“As Americans, we are very unaware of the value proposition of Poland,” says Marty Henehan, highlighting the untapped potential of Central European biopharmaceutical manufacturing for North American biotechs.
Marty Henehan, Vice President of Business Development and Head of North America at Mabion sheds light on the advantages of partnering with a Polish CDMO for drug development and manufacturing services.
Speaking to the PharmaSource podcast during CPHI Milan, Marty explains how Mabion’s transformation from a biosimilar company to a full-service CDMO has positioned them to offer cost-effective, high-quality solutions for biotechs worldwide, particularly those in North America.
Mabion’s Evolution: From Biosimilars to CDMO
Mabion’s journey began as a biosimilar company, spending over 15 years developing their own products and becoming a leader in biologics in Poland. Marty explains, “When the pandemic hit, we were approached by Novavax to make their COVID vaccine. For the last four years, we’ve been a CDMO making products for somebody else.”
This shift allowed Mabion to leverage its extensive experience in biosimilar development to serve a broader range of clients. “We still work with a lot of early phase biotech companies that need the development expertise we developed over 15 plus years,” Marty notes. “The team has responded very well because they love the diversity and the number of opportunities they get to be involved in.”
Comprehensive Services: From Gene to Commercial
Mabion offers a wide array of services catering to various stages of drug development and manufacturing. Marty details their capabilities:
“We offer everything from cell line development, so from gene to commercial. We can help in cell line development, select the clones for preclinical and Phase One opportunities, develop molecules to be more robust, and manufacture at clinical scale.”
The company’s flexibility is evident in its manufacturing capacity. Marty explains, “We can scale up to 2000 litres. We have four 2000-litre bioreactors that can be run individually or as a combination. We’re able to manufacture at a large scale for some clients, but also flexible enough at small scale for early phase projects.”
Cost-Effective Manufacturing in Poland
One of Mabion’s key advantages is its location in Poland, offering significant cost savings compared to US-based CDMOs. Marty provides a striking comparison:
“At a 2000-litre bioreactor scale, our pricing would probably be somewhere about 50% of a US market, about a third less than the rest of Europe, and on par with what you might expect to pay for a 2000-litre bioreactor run out of Asia.”
This cost-effectiveness doesn’t come at the expense of quality or regulatory compliance. Marty emphasises, “Poland is part of the EU and has been for 20 plus years. Their GDP has been outgrowing the rest of Europe over that entire 20-year period.” He adds, “The majority of our workforce have advanced degrees, so it’s a very highly educated workforce with lots of experience.”
Navigating the Biosecure Act and IP Protection
Addressing concerns about intellectual property protection and the Biosecure Act, Marty clarifies its international nature: “It’s not a US act. It’s a collaboration between Canada, North America, and Europe.” This collaboration aims to encourage local business while protecting intellectual property rights.
Marty explains the act’s importance: “It’s about allowing our clients and developers to bring a product to market and realise that for a period of time, and be able to reap the benefits of the cost and investment they’ve made.”
Market Outlook: Optimism in the Biotech Space
Despite recent slowdowns in investment, Marty sees positive signs for the biotech industry. He observes, “What we’ve seen throughout the shows in the last couple of weeks is people are very bullish on the market and opportunities.”
This optimism is particularly evident among early-phase companies. Marty notes, “There’s a lot of early phase people that believe they’re getting ready to be funded, looking for opportunities and partners to manufacture their product. They’re lining up their clinical trials and actively engaging in what the next steps are.”
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