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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.
With the advent of more product niches and often lowered production quantities, facilities that are experienced and versatile in handling cytotoxic, highly potent, and non-cytotoxic oncology products can present a valid option when considering outsourcing.
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
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