Our scientists provide development support for a wide range of pharmaceutical dosage forms with specialist expertise in OINDP development with integrated formulation and testing services for both small molecules and biologics. Our teams carry out early-stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing, and device selection support. For inhaled biologic development, comprehensive protein characterisation services supported by forced degradation and stability monitoring for the protein’s structure and bioactivity throughout formulation and storage can also be provided. Interaction with the device and closure systems are evaluated through comprehensive extractable and leachable testing and toxicological assessments.
With 30 years of experience in supporting our clients’ inhaled and nasal product developments, we deliver world-class support to help you meet the challenges of your demanding development programs. The Intertek Melbourn 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.
Intertek Melbourn
Saxon Way
Melbourn, Royston, Hertfordshire SG8 6DN
United Kingdom
+44 (0)1763 261 648
www.intertek.com/pharmaceutical/melbourn/
bd.melbourn@intertek.com
WEBINAR | Repurposing Products for Inhaled Delivery - Rapid Response Strategies
Inhaled administration offers significant repurposing opportunities for both local and systemic therapeutic delivery and vaccines. Redevelopment must be fast, effective and accurate with tight control over quality in order to get a drug ready for clinical trials. In this webinar, we describe strategies required for rapid repurposing for inhaled delivery, discussing considerations whilst mitigating anticipated challenges. More Info
On-Demand Webinar | The Challenges of Developing Biologics for Respiratory Delivery for Respiratory Delivery
Developing biologics for respiratory delivery presents a range of new challenges. The device, formulation, active substance, excipients and manufacturing processes all influence the performance, usability and functionality of the product and need careful consideration during development. During this webinar, DFE Pharma and Intertek review key concepts and techniques in the formulation, design, and performance testing of the formulation of biologics for Dry Powder Inhalation. More Info
Article | Considerations when Switching from Current pMDI Propellants to New Lower-GWP Propellants
In this article, we discuss considerations that need to be made when switching from current pressurised metered dose inhaler propellants to new alternatives with lower global warming potential, including formulation, regulatory and analytical standpoints. More Info
WEBINAR | Plume Front Velocity and Force to Actuation Characterisation of pMDIs and Soft Mist Inhalers
Characterisation of Plume Front Velocity (PFV) profiles of generic test and reference products has been used to support a weight of evidence approach to in-vitro only bio-equivalence testing of generic inhaled products. This negates the need for resource consuming comparative clinical endpoint bioequivalence studies. In this study, the differences in the PFV between the two device types (pMDI/SMI) was investigated and the PFV compared between a generic pMDI device and its reference listed drug (RLD). More Info
Presentation | Reducing Time Requirements for Morphologically Directed Raman Spectroscopy Based In Vitro Bioequivalence Studies
MDRS selectively measures particle size and morphology in multi-component blends, aiding in drug particle size characterization and inference of dissolution characteristics, potentially bypassing clinical endpoint studies for bioequivalence. However, its lengthy process poses limitations, particularly for IVBE studies requiring at least 60 replicates. This presentation looks at optimizing MDRS with API-selective microscopy which can reduce time and costs for future studies on generic nasal drugs. More Info
White Paper | Intranasal Delivery of Biologic Therapeutics and Vaccines
Intranasal administration of biologic therapeutics has potential to address a wide range of diseases. In this article, David Ward, Formulation and Manufacturing Lead at Intertek Melbourn, looks at how the nasal route of drug administration offers the potential to improve the delivery of biologics and why strategic formulation is required to make this a reality. More Info
