To fulfil cGMP in quality assurance for biomanufacturing, qualification and validation are essential steps demanded by several authorities. Since technologies must align with rigorous guidelines before they can be deemed suitable for use in a GMP ...
The fact that the pharmaceutical manufacturing process, including pharmaceutical fermentation, is still prone to human error and product loss can be more than frustrating. This is even more true when dealing with issues that are near and dear to y...
While the original definition of fermentation is ‘the anaerobic conversion of sugar to carbon dioxide and alcohol by yeast”, fermentation in the pharmaceutical industry is used to cultivate microorganisms for antibiotics, therapeutic proteins, enz...
The manufacturing process of biopharmaceuticals such as monoclonal antibodies, mRNA and bioconjugates is divided into upstream and downstream processing. Manufacturers seeking reliable automation and optimization fit for scale-up are increasing...
One would think that a sector like the fast-paced biomanufacturing industry could not get any faster. Yet, increased speed-to-market and ever more efficient manufacturing continue to drive product and process development. This is why single-use...
Upstream and downstream processing are two steps inherent to the production of active pharmaceutical ingredients (API) used in biopharmaceuticals. Upstream processing takes small quantities of engineered microbial or mammalian cell culture to g...
Cryogenic freezing is a necessary process for the preservation of molecules, cells, genetic material, blood, and tissues. Single-use technologies enable protection of such substances from contamination and failure and preserve them for long-term s...
The evolution of single-use technologies (SUTs) is among the most important developments of biomanufacturing. Large stainless-steel containers have long been used for storage and cooling of drug substances. However, there has been a shift toward S...
Single-use bioprocessing has recently experienced tremendous growth in biopharmaceutical manufacturing market share and enjoyed technological advances ranging from material properties, to implementation of Industry 4.0. In contrast to traditional ...
When CDMOs plan to expand their production capacities based on single-use technologies, it is tempting to either implement existing spare platform systems or simply "copy paste" used equipment - especially for greenfield facilities. However, it is...
Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional a...
The processes of cryogenic freezing and cryopreservation are considered essential in biotechnology for the conservation of biomaterials. Regenerative medicine and other disciplines in life sciences were allowed to make huge leaps in the treatment ...
With the emergence of many innovative approaches in the biopharmaceutical industry in recent years, life sciences companies have needed to put increasing efforts into pharmaceutical cold chain management. Many newly developed, highly sensitive ...
