With 30 years of experience in supporting clients’ orally inhaled & nasal drug product development, Intertek Melbourn provides product performance testing, method development / validation, stability, CMC support, formulation development, repurposing and clinical manufacturing capabilities.
Quality is at the heart of our business and we continue to invest in the latest equipment and state-of-the-art facilities to support our clients. This is proven time and again through regular audits from clients and the regulatory bodies including many successful FDA and MHRA inspections.
The recent expansion at our Centre of Excellence (Melbourn, UK) has focused on further expanding on our existing analytical capabilities, integrated with formulation development and stability studies to drive understanding of our clients’ products and processes, enabling our clients’ key decision-making activities throughout the product development lifecycle for both biologics and pharmaceuticals. We offer a broad range of analytical services including large molecule characterisation and potency alongside solubility, dissolution, particle morphology (Malvern Morphologi 4 ID) and other delivery performance aspects (delivered dose, aerodynamic droplet size distribution, spray pattern etc).
- Method Development / Validation
- Analytical Testing
- Formulation Development
- Device Screening
- Quality by Design (QbD) Studies
- ICH and Accelerated Stability Studies
- In-Vitro Bioequivalence Studies (IVBE)
- Clinical Trials Materials Manufacturing
- Product Characterisation Studies
- Biologics Characterisation
RESOURCES:
Webinar | Design Verification Testing (DVT) of Metered Dose Inhalers
White Paper | Intranasal Delivery of Biologic Therapeutics and Vaccines
Visit the Intertek event page
For more information, please contact inhalation@intertek.com
Inhaled and Nasal Product Testing Expertise
We conduct GMP compliant inhalation and nasal product analysis according to guidance documents from regulatory authorities (CDER (FDA), EMEA) across all stages of product development, to fit the regulatory requirements of many regions globally (including FDA and EMA) Our specialized testing capabilities include support for a wide range of products such as pressurized metered dose inhalers (pMDI), dry powder inhalers (DPI), nebulizers, nasal drug products and soft mist inhalers. We can perform all specialist respiratory drug product testing related to the critical quality attributes for these products, as well as the classical chemical and physical testing associated with other dosage forms:
- Aerodynamic Particle / Droplet Size Distribution
- Delivered Dose Uniformity
- Particle Size or Droplet Size by Laser diffraction
- Spray Pattern / Plume Geometry
- Powder and Particle Characterization
- Extractables / Leachables Testing for Inhalation Products
- Formal Product Characterization Studies (including ICH stability programmes)
Formulation Development & Clinical Manufacturing Services
Intertek Melbourn has a dedicated formulation team, with many years’ experience in developing high quality respiratory formulations, across powder and liquid platforms or repurposing existing drug candidates for inhaled or nasal delivery is a strategic route to get drugs to patients faster. We routinely work on DPI, nebulizer, and nasal formulations for both generic and NCE projects. Intertek Melbourn doesn’t hold any IP or use any proprietary technology, and instead focuses on core platforms that are easily scalable and transferrable. Our class C GMP suite is suitable for manufacturing batches for toxicological and clinical studies, up to phase IIb.
TEL: +44 (0)1763 261 648
EMAIL: bd.melbourn@intertek.com