Performance validation: HPAPI containment testing in a risk-based era

Published: 22-Jan-2018

Taking a more automated approach to validation testing paves the way to capturing more repeatable and reliable data, thereby improving levels of containment performance

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In an industry that is seeing a surge in oncology and immune-suppressant therapies, and increasing demand for high potency active pharmaceutical ingredients (HPAPIs), there is a growing need for manufactures to look at more innovative containment strategies to meet high potency handling requirements. Subsequently, as these containment strategies evolve, so too does the role of containment verification and there is a clear need to understand the potential variations in testing and differing interpretations of results.

In this article, Michael Avraam, Global Product Manager at ChargePoint Technology, discusses the key considerations linked to containment performance testing, data collection methods and the interpretation of results. He also describes some technological developments that may help to ensure more efficient and consistent containment performance testing.

Industry landscape

It’s well documented that the biopharma market is continuously expanding, largely thanks to the global demand and growth in the oncology market. By the end of 2024, the cancer segment is projected to reach close to $100 billion in value, expanding at a CAGR of 6.5%.1 This has led to an increased need for the development of potent compounds and an increase in conventional drug manufacturing using HPAPIs.

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