Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
Respiratory Drug Development eBook – Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
EXECUTIVE INTERVIEW – Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
DEVICE REGULATIONS – The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome, and describes how the design and development of the BD Libertas(TM) is an attractive proposal for pharma companies.
EXCLUSIVE ONLINE CONTENT
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LEO Pharma and Portal Instruments Announce Collaboration to Develop Needle-Free Drug Delivery Device
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