Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric Outcomes

The environment for developing an injectable drug device combination product (CP) is dynamic from a regulatory and technical perspective. At the center of it all are the patients and their needs. West is pleased to announce the publication of its review manuscript that provides a detailed overview of best practices for this kind of development program. It considers technical and regulatory aspects and can be used as a foundational document for drug formulators, scientists and engineers working in this area.

Creating a holistic, well rounded approach that puts management of risks at the center of development will be critical to address key CP issues, including:

• Developing a strategic plan for CP development, study designs, and regulatory approval
• Merging aspects of design controls with Quality by Design (QbD) concepts
• Acquiring appropriate data to meet evolving global expectations
• Utilizing the total product lifecycle model (TPLM) with feedback loops at CP inception
• Building line of sight data packages to support development through regulatory approval
• Generating a deep understanding of product and process to minimize development and post approval changes
• Creating a two-way communication channel with transparency throughout the supply chain

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Awareness of the ever-changing technical and regulatory landscapes in the pharmaceutical industry is an essential element of West’s focus on the safe and efficient delivery of drug products. For more on how West can support CP development, contact an Account Manager or Technical Customer Service (TCS) representative.