Pharmaceutical Technology
May 15, 2019
Features
2019 eBook
1
Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.
May 15, 2019
Features
2019 eBook
1
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.
May 15, 2019
Features
2019 eBook
1
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.
May 15, 2019
Features
2019 eBook
1
Empty and prefilled syringes must pass a range of quality control tests.
May 15, 2019
Features
2019 eBook
1
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.
May 15, 2019
Features
2019 eBook
1
A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
May 15, 2019
Features
2019 eBook
1
The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.