This webinar reviews the impact of regulatory changes related to elemental impurities testing, guidance on the best routes to compliance, and an overview of the elemental impurities risk assessment process.
Design of experiment (DoE) is the centerpiece of analytical quality by design. A DoE assay development pipeline approach delivers optimized, robust, and rugged analytical methods ready for method qualification.
Biopharmaceuticals tend to be highly unstable. A pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage.
Get insights on key considerations for a successful process transfer for manufacturing a drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.
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