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Insights to evaluate inhaled product performance
Developing successful inhaled therapeutics requires expertise in formulation chemistry, aerosol science, device performance, and biological considerations.
Early-stage development teams often face challenges identifying the right partner to generate the feasibility evidence required for high-stakes development decisions. While many organizations provide specialized services, developers frequently find themselves choosing between two common models: contract development and manufacturing organizations (CDMOs) or academic research laboratories. While each play important roles in the development ecosystem, neither is typically optimized for the needs of early-stage inhaled therapeutic programs.
The Early-Stage Evidence Gap in Inhaled Therapeutic Development
Many developers of inhaled therapeutics face an evidence gap: They need credible, decision-enabling data to evaluate formulation, device, and development strategies before committing significant resources to downstream preclinical studies or large-scale manufacture. That data must be interpretable, accessible, and ready to hand off to product development and funding partners.
RTI bridges this evidence gap, providing objective and rigorous evidence that is vital to inform decisions to advance, pivot, or stop development before making substantial investments in later-stage activities.
A Milestone-Driven, Collaborative Bridge for Inhaled Therapeutic Development
RTI operates at the intersection of rigorous science and commercial product development, bringing together actionable and credible preliminary feasibility data, right-sized for your early-stage program.
These data, when interpreted by an expert scientist, help clients evaluate product potential, guide development decisions, and prepare for downstream preclinical studies or transfer to external manufacturing partners.
Why Drug Developers Choose RTI for Inhaled Therapeutics
RTI’s reputation is anchored in decades of inhalation science expertise with a product-development mindset to help clients make informed decisions during early-stage development. Our involvement in "high-risk, high-reward" programs provides our commercial partners with unparalleled institutional credibility.
RTI also serves as a strategic scientific partner for organizations pursuing Small Business Innovation Research (SBIR) grants and other translational funding opportunities, providing feasibility evidence, technical interpretation, and documentation needed to support funding applications and prepare for downstream preclinical studies or transfer to external development and manufacturing partners.
Inhaled Therapeutic Services
Formulation and small-scale manufacturing
We provide benchtop-scale formulation development and manufacturing to evaluate carrier systems and process variables, ensuring the formulation is optimized for aerosolization and documenting conditions to facilitate a smooth transfer to downstream production.
Physicochemical baseline characteristics
We establish foundational material attributes to evaluate morphology, crystallinity, and thermal behavior and identify attributes that could negatively affect long-term stability or aerodynamic performance, preventing costly surprises during later-stage development.
Aerosol and device testing
Using Next Generation Impactor (NGI) testing per USP <601> and <1601>, we quantify critical performance metrics to generate quantitative evidence of aerosol performance and respirable dose delivery.
Physiologically relevant and differentiated testing
To approximate real-world use, we can incorporate oropharyngeal casts and breathing simulators to gather evidence as to whether a product will perform consistently across diverse patient populations with varying breathing capacities.
Controlled stability testing
We provide structured storage, from cold chain to ambient to accelerated conditions, to monitor physicochemical and aerodynamic changes over time. This ensures that the formulation-device combination can maintain efficacy through the supply chain and to the point of use.
Our Experience Includes:
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Sara Maloney
Sara Maloney
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Anthony Hickey
