INHALATION DRUG DELIVERY ARTICLES
Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes.
INHALATION DRUG DELIVERY RESOURCES
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By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.
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Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
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Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.
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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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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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This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
INHALATION DRUG DELIVERY SOLUTIONS
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How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
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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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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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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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Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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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.
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A focused look at how low‑GWP propellant technologies support sustainability goals while preserving inhaler performance, offering guidance for planning regulatory readiness, device compatibility, and long‑term respiratory portfolio strategy.
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Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
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Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).
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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.