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...
For some time now, scientists have been discussing the challenges associated with freezing biopharmaceuticals in sterile bottles – especially the risk of cryoconcentration and how it might affect product quality. So, we decided to take a closer l...
Blast freezers have emerged as a reliable solution in the biopharmaceutical industry. However, pharmaceutical bulk freezing is not just about turning liquids into solids; it is also about preserving the integrity and quality of life-saving drug s...
One could read a lot about single-use bags in biopharmaceutical industry as a primary packaging in bioprocessing in the previous last years. The rise of bags has become more relevant, since they largely replaced single-use bottles. Nevertheless, s...
Despite the popularity of single-use bags for primary packaging, single-use bottles remain critical for storing, transferring, and sampling media, buffers, and drug substances throughout the biomanufacturing workflow. These sterile, reliable, and ...
The hidden risk in biomanufacturing Manual bottle filling in biopharmaceutical production is more than a routine task - it’s a high-stakes responsibility. From upstream cell culture to downstream purification, every step is tightly controlled - un...
The development process for biosimilars involves an extensive testing period in order to establish similarity to the reference biologic. To ensure that the drug doesn’t have unwanted side effects, there is a broad regulatory framework developers o...
The growing demand for biosimilars and significant increases in the biosimilar market call for innovative solutions for their fluid management and freeze thaw processes. This relates to steps like filling and filtration, freezing and thawing, a...
Biologics are a comparatively new class of drugs, nonetheless based on an ancient principle: utilizing living organisms to obtain substances that positively affect health. This approach, however, has expanded from using, e.g., plant parts for cura...
Plate freezing is a process where a product’s temperature is reduced by the means of contact with cold surfaces. Thus, a defining step in the freeze-thaw process for conservation in flat primary packaging, such as single-use bags. Things ...
Monoclonal antibody production is one of the most thriving branches of the pharmaceutical industry. The enhanced interest in antibody production is due to the success of antibody treatments which are used to trigger an immune response against infe...
In the dynamic landscape of pharmaceutical manufacturing, the journey from laminar flow to automated fluid management has been nothing short of transformative. This evolution, marked by innovation and adaptability, has reshaped the way smaller vol...
