CDMOs are investing billions in European API capacity. Companies are responding to risks related to demand and supply chains. 24-Sep-2026 contract development and manufacturing organizations (CDMOs) are ramping up their active pharmaceutical ingredient (API) investments in Europe. A series of recent deals shows how companies are strengthening their infrastructure in the region, as they position themselves to develop and supply newer, more complex medicines, says GlobalData, a leading intelligence and productivity platform. GlobalData's monthly Bio/Pharmaceutical Outsourcing report reveals that the expansion of CDMO API capacity in Europe is taking place across several stages of the pharmaceutical value chain and has two main drivers: evolving demand and sensitive supply chains. Edita Hamzic, Healthcare Analyst at GlobalData, says: "Demand is changing. GLP-1s, peptides, biologics and other advanced therapies require more specialized manufacturing than many traditional medicines. Supply chains have become more sensitive to disruption risks; building capacity closer to European customers can provide greater supply security." There were four API investments between July and August 2026. The largest commitment comes from Bachem, the Swiss peptide and oligonucleotide CDMO, which plans to invest more than CHF500 million (about $609 million) in a new large-scale production facility at Sisslerfeld in Eiken, Switzerland, its third Swiss site. The main driver is demand for peptide APIs, particularly the rapid growth of metabolic medicines such as GLP-1 drugs for obesity and diabetes. Cambrex is investing $30 million in a new R&D facility at its Milan site. The project will add analytical development and process R&D capabilities and upgrade existing production plants, with completion expected in H2 2027. Cambrex has also acquired adjacent land for future expansion. The investment will support the earlier stages of drug development and strengthen Cambrex's ability to develop and scale complex small-molecule APIs before they reach commercial production. Théa Group and Unither Pharmaceuticals are developing a 20,000-square-meter facility in Gannat, France, with an investment of more than EUR140 million (about $161 million). Unlike a typical CDMO facility serving multiple customers, this site will be primarily dedicated to manufacture Théa's sterile ophthalmic products for the French and wider European markets. The facility expands Théa's European manufacturing capacity and supports its long-term growth. Meanwhile, German pharma group Merck, which provides CDMO services on an 'excess capacity' basis, has opened a EUR25 million (about $29 million) BioReliance testing facility in Darmstadt, Germany. The 2,000-square-meter site provides drug-substance and drug-product release testing and GMP-compliant stability studies for monoclonal antibodies and cell therapies for the company's biopharmaceutical customers. Hamzic concludes: "In addition to their importance to the companies concerned, the investments also have a strategic dimension for Europe as a whole. They will build specialized skills and jobs, strengthen pharmaceutical networks, and reduce the region's dependence on outside manufacturing capacity."

North Penn creates fund for disputed Merck tax payments. Business is paying tax bill 'under protest,' says superintendent. PUBLISHED: September 23, 2026 at 10:14 AM EDT LANSDALE - A new fund has given a hint at what could be a long-running dispute between the North Penn School District and one of its largest taxpayers. Board members voted last week to create a fund meant to keep a disputed tax payment by Merck broken out from the rest of the district's revenues. "It is no secret, it has been well-publicized in the school district and covered by our local media, that there is a tax assessment appeal that we are currently working through with our neighbors at Merck," said Bauer. "Because that has not been resolved, and because real estate tax bills go out during the summer, and are due over the summer, Merck is paying their taxes, but under protest, because we are currently in an appeal," he said. In early May, Upper Gwynedd's staff asked that township's commissioners to approve a contract for new assessments of two properties in that township, and at the time, Bauer said Merck had filed an appeal on the values of two parcels that generated over $16 million annually in tax revenue to the district. Later in May, the district's solicitor said the board met in executive session "to discuss litigation involving a tax assessment appeal," and in early June, the district said budget figures were still being finalized, with a $3.4 million number 'set aside' by finance staff as 'allowances for tax assessment settlements' in the anticipated expenses for the 2026-27 budget year. After that budget was adopted in June, the board voted unanimously to hire a special counsel to handle the matter, and last week Merck presented plans to Upper Gwynedd's commissioners for a new manufacturing building on their West Point campus; in talks on that presentation the township's solicitor said the assessment of that site was the subject of ongoing negotiations. In their Sept. 17 action meeting, the superintendent closed out his list of action items requested for approval from the board by asking them to OK a motion creating a new bank account with Univest Bank "for the purpose of Merck escrow funds," then explained details. "Given the magnitude of the actual appeal, when they are paying in protest we have to escrow 25 percent of their taxes. So this creates an account to separate those funds, and set them aside until we resolve the matter. That's the reason for this motion," Bauer said. After that motion creating the new account was unanimously approved, a separate action item gave a hint at the numbers involved. Assistant Director of Business Administration Mary White presented the district business office's monthly financial reports to the board, and the July 2026 report includes a line item "Escrow account for taxes paid in protest" of $1,588,165.96. Per that same report, the district received just under $29 million in tax revenue in July and spent just under $19 million, with a total of just under $128 million in total available funds as of the end of that month. "The total balance will dramatically increase over the next several months, due to the revenue collected from real estate taxes," White said. North Penn's school board next meets at 6 p.m. on Oct. 6, and the board finance committee next meets at 6 p.m. on Nov. 5, both at the district Educational Services Center, 401 E. Hancock Street. For more information, visit www.NPenn.org.

How to build pharma AI audit trails. September 22, 2026 - Sponsored by Adlib Software | Editorially Independent A pharmaceutical regulatory response team spends 30 days on a single agency question. Most of that time goes to finding documents. At the Industrial AI Summit 2026, Kristen Sauter, President and General Manager of Life Sciences, Adlib Software, and Adam Procopio, Scientific Associate Vice President, Merck, explained why: every time a contract manufacturer's electronic batch record crosses into the pharmaceutical company's system, it arrives as a PDF stripped of the structure that AI needs to trace decisions back to source data. Why do documents break AI traceability in pharma? Every time two systems exchange data, a new generation of documents gets produced. A contract development and manufacturing organization may run a full electronic batch record internally, capturing sensor-level values in a structured digital format. When that record arrives at the pharmaceutical company, it has been converted to a PDF. The structure that existed at the origin is gone. Engineers look at the model, auditors look at the record, but traceability fails at the documents that sit between the two. The number of system interactions is increasing, and each interaction regenerates documents in ways that lose structure. Adam calls this problem "unknown knowns": the data exists somewhere in the enterprise but is very difficult to find. Maya Schushan-Orgad, Sr. Director, Open Innovation Platform Lead, Teva Pharmaceuticals, added that the heterogeneity of machines and formats across manufacturing sites compounds the problem, making it harder to trace data back to its origin. Who owns traceability when a partner manufactures the product? Pharmaceutical companies outsource manufacturing to CDMOs but retain full regulatory accountability for the dossier. "We can outsource the work. We can't outsource accountability," said Adam Procopio, Scientific Associate Vice President at Merck. Regulators expect the pharmaceutical company to own the integrity of every document behind a filing, including data generated in a partner's facility. The pharmaceutical company must ingest fragmented spreadsheets, scanned batch records, and non-readable PDFs from external partners and convert them into a data schema that its own AI systems can reference and cite. Two years ago, structuring decades of legacy unstructured data would have been described as an insurmountable task. Adam noted that agentic AI approaches have changed that calculation: tasking an agent to structure unstructured data is now feasible for organizations willing to spend on the tokens. Should companies fix their document archive or start fresh? Adlib's answer: start today, work forward, and do not begin with the archive. Reconstructing traceability after the fact is not defensible. Building it at the source is the only approach that survives regulatory scrutiny. Agencies and health authorities are moving toward data-driven submissions, which means positioning current data practices for that future rather than spending resources on a backlog that predates modern data requirements. When asked about reconstruction, the response was four words: "Don't do it." The FDA's recent guidance on AI in regulatory decision-making represents, in Adlib's assessment, a signal that the agency is open to discuss AI utilization, not a blueprint for implementation. Companies calibrating how aggressively to adopt AI-driven compliance workflows should read the guidance accordingly. This article is based on a panel discussion at the Industrial AI Summit 2026 featuring Adam Procopio of Merck, Kristen Sauter of Adlib Software, and Maya Schushan-Orgad of Teva Pharmaceuticals, moderated by Rick Franzosa of Tech-Clarity. AI tools were used to help summarize and organize the content. Reviewed and edited by the IIoT World editorial team. Editorially Independent, Sponsored by Adlib Software