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Live Webinar

Testing of Bioprocess Residual Impurities in Gene Therapy Products

Sciex 4500Thursday, November 7, 2019 | 11 am EST

The manufacture of gene therapy products can be a complicated process. Multiple cell culture systems and a variety of process additives are often necessary to produce vector intermediates and the final bulk drug substance. To ensure the safety and efficacy of gene therapy products administered to patients, manufacturers are expected to measure and control impurities in drug substance, as well as manufacturing intermediates (where applicable), including host cell, vector components and process additives. Tracking the clearance of these residuals is also an essential part of process development and characterization. Due to the complex nature of gene therapy product manufacture, analytical method development and validation of these methods can be challenging. Furthermore, detailed regulatory guidance on acceptable limits are not available for all possible residuals.

During this presentation, you will learn:

  • Typical residuals associated with the production of gene therapeutics
  • Analytical approaches for residuals testing
  • Challenges with platform method technology for residuals
  • How to deal with matrix effect

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On-Demand Webinar

MLT TestingBurkholderia cepacia complex (Bcc) testing for Non-Sterile Water-Based Drug Products is coming—Get ahead of the game

During this webinar, our expert Holly Deitrick will present an overview of Burkholderia cepacia complex (Bcc) testing, testing for absence of Bcc, the FDA Guidance on prevention and detection of Bcc microorganisms, and how Eurofins BioPharma Product Testing can support your Bcc testing needs.

Topics Include:

  • The history of Burkholderia cepacia complex
  • The health risks associated with these microorganisms
  • Recalls associated with contamination of BCC organisms and the lessons learned
  • A glimpse of the current USP draft for BCC testing (USP chapter <60>)
  • Burkholderia cepacia test methodology and best practices
  • And more

Click here to watch this on-demand webinar


On-Demand Webinar

Navigating the Challenges of Residual Solvents in Pharmaceutical Products According to USP <467> <1467> and ICH Q3C Regulatory Guidelines

July 24, 2019 | 11 am CDT

Understanding the regulatory expectations of residual solvents is not always easy, especially the recently published changes from the USP. During this webinar, Eurofins BioPharma Product Testing’s experts will provide a detailed summary of the changes and logical approaches for satisfying the new USP instruction, including approaches for a wide range of product types to help solve your residual solvents challenges with practical and cost effective strategies.  We will share case studies addressing problematic solvents and the technical path forward.  This webinar will also include:

  • A Review of USP Screening Residual Solvents for Excipients, Drug Substances and Drug Products
  • An Overview of limit vs. quantitation procedures and <1467> validation
  • Options for Class 2, Mix C and Class 3 Residual Solvents testing
  • Case studies for problematic solvents and the strategy Eurofins BioPharma Product Testing uses for successful testing
  • Discussions on NCE or non-compendial test articles and ICH Q3C

Presenters:

Erika GuerreroErika Guerrero
Principal Scientist/Group Leader
Eurofins BioPharma Product Testing
Danielle NewtonDanielle Newton
Senior Scientist/Group Leader
Eurofins BioPharma Product Testing
Harley WilcoxHarley Wilcox
Small Molecule Senior Scientific Advisor
Eurofins BioPharma Product Testing 

Click here to watch this on-demand webinar

University of WisconsinThe Division of Pharmacy Professional Development at the University of Wisconsin and Eurofins BioPharma Product Testing are proud to bring you this live webinar.


On-Demand Webinar

Cell Based Bioassays

Cell based bioassays are critical to determining the potency of biopharmaceuticals. The ICHQ6 B defines potency as “The measure of the biological activity using a quantitative biological assay based on the attribute of the product which is linked to the relevant biological properties.” Potency directly reflects the subtleties of the tertiary and quaternary structure of a biopharmaceutical in a manner in which physicochemical methods are incapable. But cell bioassays are also challenging as they involve use of living systems and their inherent variability. This webinar will discuss:

  • Types of bioassays
  • Challenges
  • Lab design
  • Development and Validation

Glenn PetriePresenter:
Glenn Petrie, Ph.D.
Biologics Senior Scientific Advisor
Eurofins BioPharma Product Testing

 

Click here to watch this on-demand webinar

University of WisconsinThe Division of Pharmacy Professional Development at the University of Wisconsin and Eurofins BioPharma Product Testing are proud to bring you this live webinar.


On-Demand Webinar

Inhaler

Inhalation Performance Testing: Requirements and Common Challenges

Inhalation performance testing poses unique challenges in the quality control (QC) testing arena due to the complex role the device plays.  Many inhalation products are true drug/device combination products, such as pMDI and DPI, in which the container closure system plays a vital role in administering the dosage to the patient.  These combination products require not only normal QC testing, but also performance testing to ensure proper dosing and full extractable and leachable evaluations.  As a result, these complex combination products can pose a series of challenges when implementing routine QC testing.  This webinar will include case studies, along with an overview of the following:

  • Overview of testing requirements
  • How to develop robust QC testing methods
    • Analytical methods
    • Sample preparations
  • Common challenges encountered with performance testing
    • Droplet size distribution
    • Content uniformity
    • Spray pattern
  • Extractables and Leachables requirements

Click here to watch this on-demand webinar


On-Demand Webinar

Sterility Testing: Best Practices and Use of Isolator Technology

Sterility Testing WebinarSterility testing is a regulatory requirement for all preparations that according to the USP, EP, and JP Pharmacopeias are required to be sterile. Sterility testing is considered a referee test and is not intended as a sole product release test.  False negative and false positive results can occur if the proper process controls are not followed.

Many challenges are associated with achieving a suitable test environment to carry out sterility testing under the most ideal aseptic conditions; critical best practices should be followed to demonstrate an accurate, meaningful sterility test result.

Key Learning Objectives:

During this webcast, will discuss strategies and best practices for maximizing the conditions of the sterility test environment as well as reducing the risk of inaccurate results for sterility testing through the use of isolators and vaporized hydrogen peroxide (VHP). Topics will include:

  • Regulatory guidance and recommendations
  • Lab design and system overview
  • VHP decontamination cycles/load design and qualification
  • Package integrity verification for VHP
  • System monitoring and controls
  • Training
  • Method suitability
  • Sterility test methods and techniques
  • Pros and cons of isolator vs. cleanroom
  • Sterility test positive rate

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