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Swissmedic grants manufacturing license to DINAMIQS for viral vector production

ByArticle Source LogoBioProcess International – New Facilities05-05-20264 min
BioProcess International – New Facilities
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Last week, Switzerland-based contract development and manufacturing organization (CDMO) DINAMIQS announced the receipt of a manufacturing and testing license from Swiss regulatory agency Swissmedic for viral vector GMP production at the company’s facility in Zurich. The approval allows the firm to manufacture and release GMP advanced therapeutic medicinal products (ATMPs). According to the firm, the license establishes DINAMIQS as the first fully integrated viral-vector CDMO in the country.

DINAMIQS’s Zurich facility is 2,500 square meters and can manufacture viral vectors up to a 1,000-L scale. According to the firm, the facility integrates process development, drug-substance production, aseptic fill−finish, and quality-control testing. It has produced more than 300 batches of adeno-associated virus (AAV) and lentiviral vectors (LVVs).

DINAMIQS became a subsidiary of Siegfried in 2023 when the big CDMO acquired a 95% stake in the company. Martin Kessler, CEO of DINAMIQS, praised the partnership with Siegfried in a discussion with BioProcess Insider. He said that with Siegfried’s support, DINAMIQS managed to accelerate its trajectory and begin GMP build-out in late 2024.

Swissmedic performed an inspection of the site in February 2026, with the license following in April. “Our engagement with Swissmedic didn’t start at inspection,” Kessler told us. “We held multiple scientific advice meetings on facility layout, equipment, and our overall approach and afterwards incorporated their input.”

Switzerland’s role in biotech

Switzerland is home to many of the world’s biggest and best-regarded biopharma and biotech companies, with Siegfried standing along the likes of Novartis, Roche, and Lonza. Kessler told us that Switzerland is differentiated by its talent pool, which he said is “shaped by world-class institutions such as ETH Zurich, USZ, and UZH, alongside the long-standing presence of leading global pharma companies.”

He added that the presence of such prestigious research, medicine, and technology institutions feeds a collaborative biotech ecosystem. “In addition, Switzerland’s central position in Europe, paired with reliable infrastructure and connectivity, makes it an ideal location to support international programs efficiently, from early development through GMP manufacturing.”

The growth of AI

Much like the rest of the industry, DINAMIQS has integrated advanced AI technologies, which Kessler views as important to the progression of life sciences. “We are building capabilities with the expectation that advanced digital and data-driven tools will be part of standard operations,” he said. “AI already plays an increasingly important role in day-to-day work: platforms such as Copilot help reduce administrative load, while specialized AI models can support scientific tasks such as genome engineering.”

He said that the company also uses AI-enabled approaches to help predict experimental outcomes to accelerate learning cycles and improve decision making during drug development. “We see AI as a major disruptor for life sciences and the pace of investment from big tech. This is illustrated by recent announcements from companies such as Amazon and reinforces how central these technologies are becoming to the sector.”

Tackling affordability

Affordability has long been a point of concern surrounding gene therapies, which can be prohibitively expensive. “If you look at manufacturing only, low yields, and the risk of failed batches are among some major cost drivers,” Kessler told us. He stressed the importance of working with clients early and continuously on the fundamentals, such as “genome engineering, upstream and downstream process optimization, and targeted cost-optimization studies tailored to each program.”

Such an approach, he said, improves success rates and raises both yields and product quality. “Industry-wide, we now see yields that are several logs higher than five years ago, and our development strategy is designed to help clients benefit from that progress.”

“Finally, it is important to put manufacturing cost in perspective,” he said. “For larger indications, process development and manufacturing can be a relatively minor portion of the final commercial price.” He said that clinical development costs can exceed manufacturing costs by multiple times, which creates an accessibility barrier for rare and ultra-rare disease treatments. “Improving affordability will require continued innovation, not only in production, but also in how trials are designed and executed or how reimbursement models are structured.”

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