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WEBINAR: Don’t let your diluent be the weakest link in your drug product

The high cost of drug development presents drug manufacturers with numerous challenges, particularly the prevention of waste of valuable API due to imprecise dosing or overfilling, and the need to deal with limited shelf life due to the unstable nature of many of biopharmaceutical compounds. To overcome these issues, drug manufactures have largely looked to lyophilization, or freeze-drying of injectable drugs. For the reconstitution of the lyophilized drug product various diluent options are available and include different application systems like vials, prefilled syringes, or dual-chamber syringes. It is important to choose a high quality diluent to preserve the efficacy of the drug product. Considerations involved in making the right choice of a diluent program include development costs, regulatory approvals, time to market, process qualification, and packaging material preferences. Stability is also critical, particularly since water, a very commonly used diluent, presents a number of particular challenges with packaging interactions.

In this webinar we will examine the distinct advantages of prefilled diluent syringes. We will also discuss the differences between a customer specific and an established diluent program and the success factors involved in each.

By attending this webinar the participant will:

  • Gain an understanding about the key differences between vials and prefilled syringes in a diluent program.
  • Learn how to determine the key factors involved in choosing the right diluent program, and the significant advantages of an established diluent program over a customer specific program.
  • Learn about the development of a stability program for your diluent – including storage condition strategies, testing programs, and the role of packaging combination and design for qualification. 

​This webinar will be presented live twice at:

  • Asia Pacific Session: 3pm CST / 3:30pm PYT / 4pm JST  

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  • US/EU Session: 10am EDT / 3pm BST / 4pm CEST

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Date Oct 13, 2016
Location Online
Speaker Daniela Guttmann, Product and Service Manager & Dr. Karin Kottig Manager Contract Service Analytics at Vetter
Presentation Don’t let your diluent be the weakest link in your drug product
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