Fluid management in biopharma has changed considerably in recent years. With the advances in life science and the related healthcare adaptations, the manufacturing and supply chain divisions of biopharmaceutical companies are going through a major...
In this article, we will discuss the differences between CMOs (contract manufacturing companies) and CDMOs (contract development and manufacturing companies), the characteristics and types of them, the services that they typically offer, the oppor...
GMP Annex 1, the European guideline for “Manufacture of sterile medicinal products”, has been updated in 2023. The revision’s changes have added several challenges, but also chances for manufacturers in order to comply with the new regulations....
Pharma 4.0 is no longer a thing of the future. Industry 4.0 for biopharmaceutical manufacturing is here now. Innovative manufacturers are striving for operational excellence in as many areas of bioprocessing as possible. In return, they will bene...
How can biopharma supply chain risks be minimized so that patients can be provided with their medications? The supply chain is threatened by many challenges and modern types of medications such as cell and gene therapies (CGTs) aggravate many issu...
The current Good Manufacturing Practice (cGMP) regulations - originated and checked by the FDA - apply to companies operating in pharmaceutical, biotech, or med tech industries. They require the latest standards in terms of production, manufac...
In many branches and sectors, Industry 4.0 has long gone from being a buzzword to reality: In Pharma 4.0 intelligent industrial applications and IoT enable players in the bioeconomy industry - an umbrella term for biomanufacturing and biotechnolog...
Human errors in the pharmaceutical industry are a cost burden for all participants in the supply chain. 30-40% of all deviations are being caused by some form of human failure in operative handling. Even in cases where the error is considered mino...
Pharma 4.0 is the vision of digitalized pharmaceutical manufacturing. The implementation of modern digital strategies into the production of pharmaceutical drugs promises increasing productivity, easier compliance, enhanced connectivity and improv...
PUPSIT stands for pre-use post sterilization integrity testing. This method is performed once a sterilizing filter has been installed, and serves the purpose of filter integrity testing. PUPSIT ensures that the installed filter is functional duri...
First achievements of digitalization in the pharma industry All along the journey of an API (active pharmaceutical ingredient) from research & development to production and distribution, Pharma 4.0 will contribute to a process optimization to ...
Flexible and agile end-to-end solutions are essential in an extremely complex, competitive and evolving sector such as the biopharmaceutical industry. This is one of the reasons why more and more logistics solutions - covering all steps from filli...
