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On-Demand Webinar

Sciex 4500 InstrumentTesting of Bioprocess Residual Impurities in Gene Therapy Products

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

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

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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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