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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The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.
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In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.
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Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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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.
INHALATION DRUG DELIVERY SOLUTIONS
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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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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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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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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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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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Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.
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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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Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.
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Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
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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.