Nebulised Drug Product Development Services
Nebulised drug development expertise with a focus on formulation development, product performance testing, in vitro bioequivalence studies, stability, product characterisation, design verification studies, device/excipient compatibility studies, comparator studies and CMC support for NDAs/ANDAs
Nebulisers provide a proven and effective solution for delivering aqueous suspension and solution formulations to the lung. While pMDI and DPI devices have their own advantages, especially around patient experience, nebuliser delivery provides a rapid route into clinic for new chemical entities as well as a highly transferable route for biopharmaceuticals.
Nebulisers operate by atomising the drug liquid formulation into fine droplets for inhalation for both solution and suspension formulations. Performance of the nebuliser can be selected and tailored by utilising a range of technologies and designs to work in parallel to the formulation design to optimise aerodynamic droplet size and drug delivery. A strategic drug product development approach is required to maximise efficiency, reproducibility, and consistency.
Common types of devices include jet nebulisers, vibrating mesh nebulisers and ultrasonic nebulisers and as an independent development partner we have experience of working with a wide range of manufacturers and devices. Newer developments in device technologies can deliver far greater efficiency and speed of dosing, addressing some of the historic issues with this delivery route and providing an effective solution for delivery of proteins and other complex biopharmaceuticals.
Nebuliser Development Expertise
We have been supporting clients’ product development for over 30 years across all classes of inhaled and nasal delivery technologies including nebulized therapeutics. We provide expert OINDP formulation development, product performance testing and analysis, in vitro bioequivalence studies, stability, product characterisation studies, design verification studies, device/excipient compatibility studies, comparator studies, CMC support for NDAs/ANDAs, and clinical manufacturing services.
We conduct test programs with a focus on critical test parameters for nebulisers such as droplet size, the delivered dose, the viscosity of the drug and how the drug is absorbed by the lungs. Our stability team are experienced in designing and delivering robust stability studies with consistent aerosol testing methods which are critical to ensure a stable and safe product.
As the delivery efficiency is closely connected to the nebuliser technology, our experienced team can support your product development to help ensure the formulation is compatible for a specific nebuliser technology. For example, some devices may not be suitable for delivery of biological drugs such as proteins, peptide, or oligonucleotides as different technologies can introduce oxidative, sheer or heat stresses which may lead to decomposition, aggregation, or other degradation pathways and hence loss of activity.
Your Nebulized Drug Development Partner
We have over 30 years of experience in supporting clients’ orally inhaled & nasal drug product development, from early-stage development, through to in-process control and product release assays. Our nebuliser product development programs, integrated with analytical testing and stability studies, can help you to determine if your drug product delivers consistent and effective performance in line with the target product profile, maintaining performance throughout the product lifetime.
Our purpose-led vision is to make the world a better and safer place and our aim is to be the world’s most trusted partner for Quality Assurance. Intertek’s innovation-led, end-to-end Total Quality Assurance (‘TQA’) proposition helps organisations operate safely, effectively and with complete peace of mind in an increasingly complex, fast-changing world.
ON DEMAND WEBINARS
Repurposing Products for Inhaled Delivery - Rapid Response Strategies
Formulation and Manufacturing Approaches for Nasal Drug Products
Repurposing Vaccines for Intranasal Development
In Vitro Bioequivalence for Pulmonary and Nasal Delivery
Nebulised Drug Development Considerations
Assessment of Foreign Particulate Matter in DPI Formulations
GMP Pharmaceutical Analysis and Formulation Expertise
Saxon Way, Melbourn
Herts, SG8 6DN
Laboratory Expansion for Specialist OINDP Development for Biologics
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA