INHALATION DRUG DELIVERY ARTICLES
Risk Is the Spine: What The First 100 QMSR Inspections Reveal
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
INHALATION DRUG DELIVERY RESOURCES
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David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
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Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.
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Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
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Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
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Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
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This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.
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Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
INHALATION DRUG DELIVERY SOLUTIONS
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This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.
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Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.
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Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.