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Sterile Contract Manufacturing
Baxter

Webinars

In this section, you can view informative webinars about the latest in parenteral techniques and industry trends from Baxter experts.

Title

Description

Delivering Biologics With a Difference

Replay on Demand

Baxter’s proprietary GALAXY technology is currently the only manufacturer-prepared commercial scale aseptic filling process for premixed drugs in flexible IV bags, delivering the first-ever biologic in an intravenous bag. This webinar will explore the advantages, challenges, case studies and science behind delivering biologics with a difference.

    Key learning objectives:
  • Learn about the possibility of delivering intravenous-dosed biologics in an aseptically-filled intravenous bag
  • Increase your understanding of the business drivers and potential value added with this strategy
  • Increase awareness for the timeline required and ideal lifecycle timing to implement

New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy

Replay On Demand

Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation, Dr. Michael J. Pikal, Ph.D, suggests “revisions” to these historical rules.

Biosimilar Regulations and CMOs

Replay On Demand

In this webinar, moderated by Fierce Biotech’s editor, Kelly Davis, Regulatory Affairs Associate Director at Baxter BioPharma Solutions, will present in a discussion of recently-passed Biosimilar legislation. The purpose of the webinar is to help CMOs understand the significance of the legislation to their businesses and how the new legislation may help, or hurt, contract manufacturing for biologics.

Enhanced Delivery Options for Injectables

PDF

In this webinar, 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, and lifecycle management through collaboration

Shoot for Share: From Vial to Prefilled Syringe

PDF
Audio

This webinar 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

PDF
Audio/Visual*

This webinar features Baxter’s Frank Generotzky, Director of Technology & Engineering, and Corinna Schneider, QA Specialist 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

PDF
Audio/Visual*

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

*To view the webinars as WebEx files, download the free plugin here:
http://www.webex.com/lp/player/download.html

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