
The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.
Elemental impurity testing is essential to deliver safe drug products to patients and is a regulatory requirement. It is important to assess the risk of elemental impurities from all sources in the manufacturing process, including process equipment, water, container/packaging, raw materials, drug substances, and the final drug product.






