So Many Solvents, So Little Time making sense of industry and regulatory guidance on model solvents for extractables studies on single

So Many Solvents, So Little Time making sense of industry and regulatory guidance on model solvents for extractables studies on single

03/21/2017, 3:30 PM - 4:15 PM

Meeting Room 1

Language:
English

Numerous trade associations have published recommendations on extraction methods and analytical technique to identify and quantify extractables from single use processing technology that is now routinely used for drug manufacturing. Often the recommendations conflict and the application to your specific manufacturing process and drug product can be confusing. The authors will describe proven methods to select model solvents and exposure conditions that reflect your process and will result in critical data that can be used to assess the impact on drug product safety and efficacy.

Contributors

  • George Adams

    Speaker

    Director of Marketing, Provantage Validation Services

    Millipore Sigma

  • Christian Heiss

    Speaker

    Director, Provantage Validation Servies

    Merck KGaA

  • Paul Killian

    Speaker

    Director, Analytical Technologies

    Millipore Sigma

  • Jessica Shea

    Speaker

    Manager, Global Technical Services

    Millipore Sigma

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Industry guidance is conflicting. A summary of published guidance will be provided. 2. Rational selection can be made with a set of facts about your process. 3. Proven methods do exist. These methods are acceptable to regulatory authorities.

Categories

  1. Track
    Enabling Technologies to Streamline Operations

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.