Pharmaceutical Technology-05-15-2019

Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.