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 three sites across the UK and US are united for complete integration of the process, and agile delivery of the final result.

Analytical and formulation

Our OINDP group has extensive experience in formulating and testing suspensions, solutions and dry powder blends. We offer:

  • 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)

Drug product development

We can support our customers’ drug product development from the start. Our dedicated OINDP team offers specialist expertise to help eliminate hurdles and reduce time to market.

We can support New Drug Applications (NDA), 505(b)(2) and generic pathways (ANDA) for the following dosage forms:

  • Pressurised Metered Dose Inhalers (pMDIs)

  • Dry Powder Inhalers (DPIs)

  • Soft Mist Inhalers (SMIs)

  • Nebuliser solutions

  • Unit dose and multi dose nasal sprays

  • Nasal aerosols and powders

Device design and development

Our team of scientists, engineers and designers leverage our expertise in the high volume manufacture of complex devices to support early stage device development through to industrialisation in one seamless process - and in one location. Our capabilities include Design for Manufacture, rapid prototyping, in-house toolroom, in-house metrology and materials laboratory to support the development of inhaled and nasal devices which can be scaled for commercial volumes.   

We also offer selection and evaluation of suitable devices and components, including:

  • Valves, cans, actuators, dose counters and spacers for pMDIs

  • Capsule, blister and reservoir DPIs

  • Jet and vibrating mesh nebulisers

  • Pumps, containers and unit dose devices for nasal sprays and powders

  • Our Resyca® joint venture offers a unique soft mist delivery platform for orally-inhaled and nasal applications

Clinical supply

We offer manufacturing solutions for early and late-phase clinical supply co-located at the same site as our commercial-scale capability, facilitating the development of pilot-scale processes 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).

  • Pilot-scale filling with any propellants HFA-134a, HFA-227ea, HFA-152a, & HFO-1234ze

  • Dispensing and handling of high potency APIs

  • Flexible multi-dose nasal spray formulation and fill

  • Formulation and mixing process development

  • Analytical method development and validation

  • Device testing, including extractables & leachables

Process development, scale up and tech transfer

Our engineers can develop and optimise manufacturing processes to meet a variety of project requirements.

  • Single, dual fill and two stage pressure filling for pMDIs

  • Powder blending, capsule and device filling for DPIs

  • Inhaled aqueous dosage forms

  • Tech transfers & 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 experienced engineers, process experts and project managers take your product through to full scale GMP manufacture.

Commercial supply

We offer full-scale cGMP batch production of drug-device combination products, and specialist device manufacturing at any scale. We offer contract manufacturing for drug products, including:

  • pMDIs - single, dual fill and two stage pressure filling for pMDIs using propellants HFA-134a, HFA-227ea, HFA-152a and HFO-1234ze

  • Unit dose and multi dose nasal sprays

  • Nasal aerosols and powders

We offer contract manufacturing for drug delivery devices, specialising in complex inhaler and nasal devices. Whether your device is already established on the market or is in the process of entering clinical or commercial production, we will ensure it is industrialised for long term quality and with a secure supply chain.