Freezing drug substances to ultra-cold temperatures is a standard step in biopharmaceutical manufacturing. Yet, beyond simply cooling, it’s the critical quality attributes (CQA), like product safety, consistency, and process efficiency, that trul...
During the manufacturing process, delivery, or long term storage, freezing drug substance is a necessary step to ensure product quality. However, various process parameters in freezing/thawing methods are related to overall product quality. One...
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...
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 Antibody-Drug Conjugate market is poised for strong growth rates in the next five years, with CAGR projections in the double-digits, reaching over ten billion USD. "ADC companies" like Pfizer Inc, Genentech, Gilead Sciences and numerous other...
For many of the approaches taken in gene therapy, viral vectors have proven to be an indispensable means to modify the genetic material of human cells. Once the life sciences had discovered the potential of viral vectors for gene therapy, research...
In these years, we are witnessing the advent of a new era in medicine and pharma. Recent breakthrough advances in life sciences such as immunotherapy, next generation sequencing and cell and gene therapies have sparked an unbelievable acceleration...
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...
