Analytical Best Practices

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As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.