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Sterile Contract Manufacturing


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



Pharmaceutical Development for ADCs

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

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: Global Terminology, Strategy & Pathways

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

Shoot for Share: From Vial to Prefilled Syringe

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

Can’t Touch This! The Three W’s of Barrier Isolator Technology

Features Baxter’s Frank Generotzky, Director of Technology & Engineering, and Corinna Schneider, QA Specialist of GMP Compliance, and discusses:

  • How Barrier Isolator Technology differs
  • Strategies to use to validate the sterilization with vaporized hydrogen peroxide (VHP)
  • How isolators makes sense from a quality and ROI perspective

Power Up Your Analytical Methods Transfer

Featuring Baxter’s Wendy Saffell-Clemmer, Manager, Pharmaceutical Research & Development, this webinar provides insight on:

  • Critical elements of success
  • Examples of transfer for biologics
  • Regulatory guidance on method transfer and method validation
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