The global combination products market has seen a tremendous amount of growth driven primarily by the rise in new therapies to address chronic diseases and contributing to a robust drug pipeline driven by biologics. Additionally, the demand for self-administered therapies is pushing the need for new, intuitive, user-driven delivery devices. Novel technologies are also contributing to this growth by offering opportunities to improve drug uptake, reduce pain and improve patient compliance and experience.
As pharmaceutical companies advance new therapies to market, their focus is primarily on the drug or biologic. Early selection of primary packaging components and systems to protect sensitive biologics is critical and can contribute a long-term strategy.
Consideration of the delivery device and the drug-device combination is essential for patient safety and regulatory approval. Without the proper foresight and planning, significant challenges on the device side arise, including complexities related to reliability, human factors, performance testing and process validations. These challenges are often compounded by accelerated schedules after therapeutic efficacy has been demonstrated.
The evolving regulatory landscape requires pharma and biotech companies partner with a true expert who can help them navigate the new regulations successfully.
This presentation with cover:
Current market trends
Understanding Impact to Regulations -drug/drug-device
High value packaging
Combination Products: Device-Development, Analytical Testing, Manufacturing
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