Daniel Tischler

Lipid nanoparticles are multifunctional tools used in a variety of different applications, supporting mRNA as a valuable instrument in medicine and research. In this article, we will shed light on what the different applications of LNPs are.

Spray drying often leads to product losses of mAbs or vaccines of more than 30%. Plate-based freezing and thawing solutions enable controlled handling of bulk intermediates safely in a vendor-independent, modular and scalable fluid and cold chain management process. 

Microbial fermentation is a powerful, flexible microbiology process used to generate microbial cells or biomass such as proteins and enzymes for the production of vaccines and therapeutics. There are still some challenges to overcome. Many of these challenges in fermentation manufacturing can be solved by replacing traditional systems with single-use technologies. 

Microbial fermentation manufacturing is an effective method for the production of APIs, bioconjugates and smaller biologicals that play an important role in biotechnology and the production of biopharmaceuticals. Manufacturers face different challenges during microbial fermentation. Explore the 7 biggest challenges, followed by the introduction of new solutions.

The filling and freezing of large volumes for fermentation is an essential part during different production steps in upstream and downstream processing.  In the following, we will explain why it is important to act fast and how an optimization of the process can be achieved. 

When dealing with bulk drug substances, there are several risks to consider along the processing steps. Read more on the critical steps in bulk drug substance production and possible solutions – in this article.

The global distribution of pharmaceuticals is complex and demanding, requiring precise handling and storage of sensitive products. With the rise of personalized medicine and the increasing globalization of the industry, the need for safe and efficient shipping and supply chain has never been more important.

Pharmaceutical manufacturing processes, including pharmaceutical fermentation, are still prone to human error and product loss. The challenges can be overcome by moving to automated processes that eliminate the need for slow and error-prone manual handling. Adopting automated end-to-end solutions based on single-use technologies minimizes, if not eliminates, human error and product loss.

Fermentation in the pharmaceutical industry is used to cultivate microorganisms for antibiotics, therapeutic proteins, enzymes and insulin. It typically involves temperature-controlled tanks, also known as fermenters and the correct concentration of nutrients to cultivate the desired organism. Microbial and bacterial fermentation technology and the associated processes open new possibilities and are important building blocks for gene-editing, conjugates and DNA plasmids used in modern vaccine production.

Freezing and Thawing drug substances in both primary packagings, single-use bags and bottles, in one platform is possible with hybrid freezers. Biopharmaceutical manufacturers and CMOs face challenges to prevent the effect of cryoconcentration during freezing, leading to loss of product quality. Tests have shown that hybrid freezer defy cryoconcentration with homogeneous freezing of both single-use bags and bottles.

To control cryogenic freezing is not an easy task, especially when liquid nitrogen is involved. To keep small molecules chemically stable and prevent chemical degradation, the right practices have to be in place. Find out everything about controlled cryogenic freezing with LN2 in this article!

Cryopreservation is an effective procedure for the quality-preserving storage of many biomaterials. Find out what cryopreservation actually is, what has to be considered along the process and where it is applied – all summed up in this article.