Newsletter | January 31, 2023

01.31.23 -- Ensuring Success In Early Biopharma Formulation Development

Elemental Impurities Risk Assessment For Finished Drug Products

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.

Analytical Quality By Design Using Design Of Experiments

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.

Navigating Early Biopharmaceutical Formulation Development

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.

Achieving A Successful Drug Product Technology Transfer

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.