Webinar:

Demystifying Extractables Testing

Sponsored by: Parker Hannifin

Focused on:

  • Extractables

Date: 18 September

87

Time: 3PM London/10AM New York

How to extract the most from your process

With single-use technology now at the forefront of existing, new and upcoming biopharmaceutical manufacturing processes, the industry is finding that it is playing catch-up with regards to the characterization of single use components through extractable studies. Different approaches to testing have emerged in guidelines from organizations such as BPOG, USP and BPSA but how can the end-user confidently assess and mitigate risk when vendor extractable data is confusing and difficult to compare?

In this webinar, we will provide a neutral assessment of the extractable testing landscape. We will provide an overview of several key approaches, outlining their similarities, differences and key considerations to look out for when reviewing data.

We will then go on to explain the key parameters that are used in extractable testing methodologies such as time, temperature and solvent type and how they are selected to ensure the most meaningful dataset that can be applied to your process to mitigate risk.

Register now for this webinar to begin applying extractable data confidently to your process.

Presented by

Graeme Proctor,

Product manager – single-use technology (Parker Bioscience)

Graeme Proctor holds a degree in Biomedical Science from the University of Sunderland and has vast experience in R&D, project management and process engineering, having spent more than two decades in the life sciences and biotechnology sectors. His experience includes commercialization and launch of disposable products for use in scale-up and technical consultancy for manufacturing.

Nick Morley,

Principal Scientist (Hall Analytical)

Nick is a principal scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing customers in the field of E&L, helping to define the most appropriate testing protocols to meet their needs. Hall Analytical is a contract analysis laboratory which focusses on problem solving. We have an extensive range of chromatographic and mass spectrometric instrumentation, combined with highly experienced and skilled scientists, and have been developing methods for the analysis of extractables and leachables across a broad range of devices/systems for over 15 years. Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time he worked on a range of therapeutic areas including inhalation, topical and parenteral. Nick had a particular focus on biopharmaceutical and cell gene therapy products, with responsibility for defining E&L strategies, authoring E&L regulatory sections and interacting with regulatory agencies. Nick developed a leachable risk assessment process, aligned to ICH Q9 and quality by design (QbD) principles, and a sample enrichment technique which are widely used across GSK. .

Key Learning Objectives

  • Learn about the different approaches to extractable testing
  • Understand key considerations to look out for when reviewing data using the different approaches
  • Understand the reasoning behind the key test parameters
  • Understand how extractable data can help to mitigate risk

Audience

  • Purification Scientists
  • Downstream Process Development
  • Upstream Process development
  • Operations Managers
  • Manufacturing Science and Technology
  • Automation Engineers
  • Facilities Manager
  • Quality Assurance
  • Supply chain management