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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Presentations

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Features presentations from Baxter experts about various topics related to parenteral development and manufacturing available for download.

Title
Description
Pharmaceutical Development for ADCs(PDF)

This presentation by Baxter’s Lisa Hardwick, Research Scientist, and Wendy Saffel-Clemmer, Director, Research and Development, provides an overview of:

  • ADC structure and function
  • Development process (including analytical methods, stability, and lyo cycle optimization)
  • Case study demonstrating importance of determining the optimal residual water content of the freeze-dried solid
Enhanced Delivery Options for Injectables (PDF)

Baxter’s Kristie Zinselmeier and BD’s Brian Lynch present the challenges and opportunities of injectable administration, including:

  • Global market trends
  • Enhanced delivery case studies
  • Market research
  • Lifecycle management through collaboration
BIOSIMILARS (PDF)

Features Baxter's Kelly Davis, Regulatory Affairs, Associate Director, and outlines:

  • Biosimilar definition
  • US and Europe Regulatory Pathways
  • Biologics Price Competition and Innovation Act
  • 351(k) Application Requirements
From Vial to Prefilled Syringe (PDF)

Features Baxter’s Raul Soikes, Sr. Director, Program Management, and provides insight on:

  • Value proposition of moving to a prefilled syringe
  • Regulatory planning to enable the move
  • Process to move from vial (liquid or lyophilized) to syringe
  • Qualifications of partners
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