Process Insights

Coming from manual and uncontrolled freezing methods, manufacturers risk non-compliance and poor consistency when cryopreserving drug substances. Non-compliant CDMOs also risk falling out of consideration for pharmaceutical companies seeking partn...

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...

Pre-use post-sterilization integrity testing (PUPSIT) is a crucial step in ensuring the integrity of sterilizing filters used in the biopharmaceutical industry. It is performed to verify a filter’s integrity after it has been installed and sterili...

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...

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...