Our processes, integrated
Working together as partners, we support you at every stage of the development process with our wealth of experience and expertise.
Our unwavering purpose and focused centres of excellence mean we can work quickly and seamlessly – from the supply of a valve to the development, scale up and manufacturing of a new product, without distance or distractions.
Underpinning it all is our deep industry knowledge and technical capability. Whether you need guidance on early-stage development or are ready for regulatory insight and support, trust us to streamline the process.
Analytical and formulation
Our orally inhaled and nasal drug product (OINDP) group has extensive experience in formulating and testing suspensions, solutions and dry powder blends.
Our analytical and formulation capabilities include:
API characterisation and dosage form selection
Formulation development, screening and optimisation
Device and container closure system screening and selection
Aerosol and device performance characterisation - APSD, delivered dose, spray pattern and plume geometry
Reverse engineering of RLD
GLP manufacture and release
In vitro bioequivalence studies (IVBE)
Analytical method development and validation
Analytical testing services, clinical and registration stability, supply of submission-ready documents
Raw material and packaging release including GMP propellant release testing (qualified for HFA-134a, HFA-227 and HFO-1234ze)
Extractables and Leachables characterisation
Drug product development
With a holistic understanding of inhaled and nasal drugs, devices and combination products, our dedicated team can help you to foresee challenges and develop a product with a smooth route to commercialisation.
Device design and development
Our teams of scientists, engineers and designers leverage our expertise in the manufacture of complex devices to support from early-stage device development through to industrialisation in one seamless process.
Regulatory support
From strategy to submission, our experts are dedicated to supporting customers throughout the regulatory pathway — whether they are developing a new product or adopting next-generation propellants.
Clinical supply
We offer manufacturing solutions for early and late-phase clinical supply, co-located at the same site as our commercial-scale capability, supporting pilot-scale development with commercial scale in mind.
Our pilot plant comprises seven independent suites – totalling approximately 900m² of manufacturing space – to enable GMP supply of investigational medicinal products (IMPs). Capabilities include:
Pilot-scale filling with propellants HFA-134a, HFA-227ea, HFA-152a and HFO-1234ze
Dispensing and handling of high potency APIs and biologics
Flexible multi dose nasal spray formulation and fill
Formulation and mixing process development
Analytical method development and validation
Device testing, including extractables and leachables
Process development, scale up and tech transfer
Our engineers can develop and optimise manufacturing processes to meet a variety of project requirements.
We offer:
Single, dual fill and two stage pressure filling for pMDIs
Powder blending, capsule and device filling for DPIs
Inhaled aqueous dosage forms
Tech transfers and process validation
Beyond our pilot plant, we support late-stage product development and transition to commercial supply. Our processing equipment is directly scalable to the commercial processes within our manufacturing facilities, and our dedicated team of engineers, process experts and project managers can take your product through to full-scale GMP manufacture.
Commercial supply
We offer full-scale cGMP batch production of drug-device combination products, and contract manufacturing for drug delivery devices, specialising in the industrialisation and high-volume manufacture of complex inhaled and nasal devices.