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Looking for information on sterile manufacturing, parenterals, medication delivery, and more? If so, you will find helpful white papers on a variety of topics in this section.
Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization.
Identifying the failure points for a product enables the development scientist to design a formulation and process with meaningful ranges supported by data.
The ultimate goal of formulation development is a stable product. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
Provides an overview of:
A study was performed to use a more scientific approach to establish leak rate acceptance criteria
Optimizing and Leveraging Improved Efficiency
Shares considerations for optimizing the lyophilization process
Explores the benefits of Ready-to-Use IV Products
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