Newsletter | December 11, 2020

12.11.20 -- Strategies For Successful Transition To Combination Products

Demystifying Performance Testing: Strategies To Qualify Combination Products

Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Performance risks are then identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Finally, a test plan based on accepted standards is designed and executed.

Considerations In Combination Product Risk Management

Drug-device combination products are rapidly increasing in use based upon the numerous benefits they provide. Successful development and commercialization require demonstration of performance and regulatory compliance. This article is a brief review of a webinar that discussed approaches to achieving both.

Quality By Design And Design Control Roadmap For Combination Products

Quality by design (QbD) principles help to facilitate the design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

Evolving Component Technologies To Meet The Needs Of Cartridge Delivery Applications

As the industry continues to see significant growth for drug products developed in cartridges, there is a trend for pharmaceutical companies to evaluate more complex drug molecules, such as biologics, that require higher injection volume or viscosity. Current component technologies for cartridge-based drug delivery pose challenges. In order to address these challenges, the next generation of cartridge components is evolving in several ways.

Industrialization And Scale-Up Of Drug Delivery System

A pharmaceutical company and their product design partner needed a contract manufacturer capable of supporting device development, injection molding, tooling, supply chain logistics, and scale-up automation strategies. The customer had developed a novel breath-actuated pulmonary device and they were looking for the right manufacturer to assist them with product development refinement, samples for clinical trials, and, ultimately, commercialization.

The Science Behind Containment and Delivery of Injectable Medicines

From trends in self-injection systems and biologic drug delivery to discussions on how to scale up complex medical devices and compliance with governmental regulations and industry guidances, the West Knowledge Center seeks to serve the industry by providing helpful insights and information.


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