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The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
Intertek has announced an expansion of its good manufacturing practice (GMP) pharmaceutical services laboratory in Melbourn, United Kingdom, adding 6000 square feet of purpose-built laboratory and office space to bring the site’s total footprint to 46,000 square feet (1).
In a press release on May 7, 2025, the company said the expansion of the Melbourn facility—which for more than 30 years has specialized in analytical, formulation, and clinical manufacturing services for inhaled and nasal drug products—is a response to the globally rising demand from clients for inhaled biologics (1). Such routes of administration are effective in delivering biologics as well as messenger RNA (mRNA), nucleotide-based therapeutics, and vaccines that treat respiratory diseases.
“This GMP lab expansion significantly enhances Intertek’s testing and analytical capabilities, enabling our clients developing novel inhaled biologics to accelerate their drug development timelines and ensure the highest standards of quality and efficacy in their products,” Ross McCluskey, Intertek executive vice president, EMEA and Government and Trade Services, said in the release (1).
While inhaled or nasal routes allow for targeted delivery to the lungs along with the potential of reducing the amount of active ingredient needed, ensuring product performance and manufacturability, as well as clearing regulatory and commercialization hurdles, have been challenges for developers, according to Intertek (1).
"Our growing facility underscores our dedication to supporting innovation and the continuous development of safe and effective inhaled biologics,” Ashleigh Wake, Intertek pharmaceutical services director for UK and Switzerland, said in the release (1). “In partnership with our clients, we are helping to advance innovations in critical medicines that will reach patients in need worldwide."
Some of the planned features of the expanded Melbourn laboratory are advanced mass spectrometry (MS) instrumentation, including high-resolution MS, and a particle characterization laboratory able to support development of both small- and large-molecule inhaled and nasal drugs (1). Capabilities characteristic of Intertek’s Manchester, UK laboratory, such as cell-based potency assays that call for the handling of hazardous biological materials and viral analytical work, will be reflected in the Melbourn site’s new bioassay and cell culture units.
Prior to announcing this facility expansion, Intertek in December 2024 entered into a partnership with UK-based CrystecPharma, a crystal and particle engineering company that applies proprietary modified supercritical fluid technologies to improve drug performance, aiming to advance formulation science and accelerate development timelines for inhaled medicines, particularly dry powder inhaler products (2).
Intertek is the host of the inhaled and nasal drug product sector’s first dedicated forum for such types of biologics and will be holding its fourth annual Inhaled & Nasal Biologics | DNA Forum, in Cambridge, UK, on Sept. 25–26, 2025 (1,3).
1. Intertek. Intertek Expands Pharmaceutical Services Laboratory to Enhance Capabilities in Inhaled Biologics and Accelerate Drug Development. Press Release. May 7, 2025.
2. Intertek. Intertek Partners with CrystecPharma to Advance Formulation Science and Accelerate Development Timelines for Dry Powder Inhaler Products. Press Release. Dec. 11, 2024.
3. Intertek. Inhaled & Nasal Biologics | DNA Forum 2025. Intertek.com (accessed May 7, 2025).