BioPharm International, October 2024

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

Solving the challenge of better-stabilized temperature-sensitive biomolecules hinges on innovative formulation strategies.

Space-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.

The best strategy is to use a combination of complementary methods.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

How the Republican and Democrat presidential candidates might appeal to voters on this topic is starting to be seen.

There is potential to effectively marry the best aspects of mRNA as a modality, to other existing or nascent exciting platforms, such as gene editing.

Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.