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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

White Papers

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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.

Title
Description
Capabilities Overview Presentation (PDF)

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.

Capabilities Overview Presentation (PDF)

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.

Capabilities Overview Presentation (PDF)

Identifying the failure points for a product enables the development scientist to design a formulation and process with meaningful ranges supported by data.

Capabilities Overview Presentation (PDF)

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.

Capabilities Overview Presentation (PDF)

Provides an overview of:

  • ADC structure and function
  • The development process
  • Lyo cycle optimization

Capabilities Overview Presentation (PDF)

A study was performed to use a more scientific approach to establish leak rate acceptance criteria

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