Inhalation Drug Product Development Services
Orally inhaled and nasal drug product (OINDP) development services including CMC support (NDAs/ANDAs), formulation development, GMP testing, product characterisation, stability programs and clinical manufacturing services for small molecule and biologic OINDPs
The development of orally inhaled and nasal drug products (OINDP) involves a rigorous approach to formulation development, testing, stability and CMC support which are necessary to determine product efficacy, quality, safety and performance. The growing interest in OINDP products is being driven by the potential of delivery inhaled routes of administration for local and systemic therapies which offer the benefits of formulation stability coupled with patient-friendly, effective drug delivery.
With nearly 30 years of experience in supporting our clients’ product development, we provide expert OINDP formulation development, product performance testing, in vitro bioequivalence studies, stability, CMC support for NDAs/ANDAs and clinical manufacturing services. Our OINDP development team provides method development and validation, inhalation product analysis, in vitro bioequivalence studies, comparator studies, device/excipient compatibility studies, Quality by Design (QbD), formulation development, clinical trials materials manufacturing and product characterisation studies.
With a dedicated ICH stability storage facility integrated with our GMP laboratory testing programs, we manage all aspects of stability study requirements such as ICH and accelerated stability studies, at every stage of a product's development from early preclinical to commercial batch stability.
With specialist capabilities in development support for inhaled biologics, our scientists deploy strategic programmes of orthogonal analytical methods which aim to fully characterise the biologic entity and to establish whether the device delivery mechanism (e.g. actuation through an inhaler) has adversely affected parameters including structure, purity (aggregation, degradation, etc) and the activity of the biologic drug in line with the ICH Q6B Guidance.
Intertek's team of expert formulation scientists has extensive experience in product development of inhaled products including all types of dry powder formulations and devices, nebulised solutions/suspensions and metered dose inhalation (pMDI) product types, as well as a range of other novel respiratory delivery systems. Our unique project management approach enables you to interact directly with our expert scientists as the development process advances.
Inhalation Product Development Experience for Product Classes:
- Pressurized Metered Dose Inhalers (pMDI)
- Nasal Sprays (aqueous, powder and propellant-driven)
- Dry Powder Inhalers (DPI)
- Nebulizer Solutions and Suspensions
- Aerosol Based Healthcare Products
- Soft Mist OINDPs
Inhalation Drug Product Development Services:
- Chemistry, Manufacturing, and Controls (CMC) Testing and Support
- Inhalation Drug Product Analytical Services
- In Vitro Bioequivalence Studies
- Comparator Studies
- ICH Stability Studies
- Accelerated Degradation Studies (forced degradation)
- Device Compatibility Studies
- Formulation Development
- Method Development and Validation
- Quality by Design (QbD) Studies and Method Optimisation.
- Product Characterisation Studies (e.g. patient in-use / misuse, spacer and cleaning studies, etc.)
- Device Verification Testing
- Clinical Release Testing
- Finished Product Release Testing
- EU Import Testing
- Visible / Sub-visible Particulate Contamination Analysis and Identification
- Pharmaceutical Powder and Particle Morphology
- Extractables and Leachables studies
- Drug / Packaging Interaction Studies
- Clinical Trial Materials Manufacturing
Our inhalation product experts have been working in the inhaled and nasal fields for nearly 30 years and possess the necessary experience to help design, implement and support full development, stability and testing services which are designed to provide the right information at the right time. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory expectations.
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