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Presentations

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

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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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