Intertek Melbourn

Intertek Melbourn has provided GMP pharmaceutical analytical testing and formulation development services to the global pharmaceutical industry for over 30 years. 

 
Our team of scientists have a reputation for providing outstanding and responsive customer service from our Melbourn Scientific Ltd laboratory, located near Cambridge, UK, which was acquired by Intertek in 2013. Intertek Melbourn opened a second facility in 2015 following increased client demand for stability storage. In 2019 a further expansion was announced which has doubled our laboratory footprint at the present location followed by an additional expansion in 2025 of office space and purpose-built laboratories focused on inhaled biologics drug development.

Why partner with Intertek Melbourn?

• 30+ years’ experience in inhaled product development and experts in rapid development strategies
• We have the largest GMP facility in Europe for OINDP development support
• Our methodology is built on our experience in supporting our clients’ in thousands of unique inhaled projects (over 5000 in the last 10 years)
• We are the only specialist OINDP Development CRO in EU to have extensive experience across both biologics and small molecule
• We have one of the largest ICH stability storage facilities in Europe with 375,000L capacity with further potential expansion capacity

Intertek Melbourn has specialist skills and experience in analytical testing and formulation for both small molecule and biologic orally inhaled and nasal drug products (OINDP), alongside all other pharmaceutical dosage forms. Clients include major pharmaceutical companies, drug delivery innovators, consultants and virtual companies. Intertek Melbourn has invested continually in the latest equipment and provides a range of services; pre-formulation and formulation, analytical support, method development and validation; stability studies, stability storage, GMP batch release testing and clinical trial materials manufacturing.

Our Intertek Centre of Excellence for Inhaled Biologics deploys a strategic programme of orthogonal analytical methods which aim to both fully characterise the biological entity and establish whether the device delivery mechanism (e.g. actuation through an inhaler) has adversely affected parameters. We have combined our 30 years of experience in biologics characterisation, from small peptides up to monoclonal antibodies and conjugated species, and contract testing, formulation and clinical manufacturing services for inhaled and nasal drug products to help you overcome the complexity in developing biologic drugs for delivery via the lungs and the nose. 

The laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. The Laboratory has also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections.

Pharmaceutical Services:

• Inhaled Product Development
• Inhaled Product Analysis 
• Inhaled and Nasal Biologic Drug Development and Testing
• Nasal Drug Product Testing and Development
• Drug Repurposing for Inhaled or Intranasal Delivery Routes
• Nebulised Drug Product Development Services
• Pharmaceutical Analytical Services
• Pre-formulation and Formulation Development
• Analytical Method Development and Validation
• cGMP Stability Studies 
• ICH Stability Storage Outsourcing
• Pharmaceutical Powder and Particle Morphology
• Chemistry, Manufacturing and Controls (CMC) Support
• Clinical Trial GMP Manufacture
• QC Testing
• GMP Batch Release Testing
• Dissolution Testing
• New Service: Fast to Clinic Formulation Platform for Dry Powder Inhaler (DPI) Products

In Vitro Test Methods for Nasal Drug Products - Part1 - AINI

Intertek Melbourn - 30+ Years Experience in Drug Development