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Pharmaceutical Manufacturing and Packing Sourcer

Managing an Extractables and Leachables Strategy in 2021

Fundamentally, an E&L strategy should be patient centric. You should keep in mind at all times that the aim is to study the risk that a patient will be taking a drug product and it could be affected by a leaching, washing, or migration of substances, collectively known as leachables. Leachables can affect the drug product in two main ways:

1. An effect on quality of the product – a reduction or change in the efficacy

2. The safety of the drug product – this is generally due to presence of toxic substances either directly introduced during manufacture or storage

For different clients, these may have different meanings; I would be working with clients to understand the risks on the basis of the points above. How is the drug product used? What level of exposure to leachables might that might then entail? I work closely with clients to define these risks through a detailed leachable risk assessment process, potentially covering all aspects, where leachables enter the drug product, such as in manufacture and packaging, followed by use cases. This risk management approach is a key step as it makes the stages that follow science-led and logical.

Project Managing an E&L Strategy

There are a few different challenges when managing a strategy, some of which are technical in nature, and others that might be described as ‘process related’.

A key challenge is obtaining knowledge and understanding around the system being studied. For example, in order to establish if the risk from leachables needs further risk reduction or mitigation, it is very important to establish what the potential sources of leachables are. This, in some cases, is quite simple to pinpoint, such as the storage of tablets in a plastic container, but in other cases, such as a complex biopharmaceutical manufacturing process, there are many potential sources from the many materials contacting the liquid drug product stream, all of which need to be considered.

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Jason Creasey, Managing Director at Maven E&L Ltd, a specialist consultancy company, established in 2019 by Jason after working in the area of extractables and leachables since the mid-1990s. Before setting up Maven E&L, he was a director of a team of analytical chemists responsible for GSK’s global R&D support for E&L across a wide range of product types and modalities. Jason was asked to comment on original 2006 PQRI recommendations and has co-authored an E&L book chapter within the Leachable and Extractables Handbook. Since setting up Maven E&L, Jason continues to present, discuss, and write about E&L and is now publishing a regular E&L blog via LinkedIn and Maven E&L’s website. As well as supporting client projects, he is working and commenting on risk management of leachables, which he hopes will form part of any ICH guidance.
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Jason Creasey
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