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...
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...
An explanation and definition of bulk filtration: What is bulk filtration, what are the different filtration methods and what did bulk filtration look like before single-use technologies came along? The filtration of liquids – commonly done in bul...
Automated Bulk Drug Substance Filling Systems fully embedded in end-to-end process streams. Several surveys have shown that more than the half of CMOs and Biopharma manufacturer still use manual filling to dispense and aliquot drug substance in...
At an increased rate, big players in the pharmaceutical industry are moving away from immobile and rigid systems with bulky stainless-steel vessels and fixed attachments towards more flexible and scalable single-use filtration systems, commonly co...
Not least since it was recommended by the FDA as a way to reduce the still-existing risk of contamination of bulk drug substance, single-use technology based on the application of disposable components has found validation and has seen a rise in p...
When it comes to the manufacturing and development of biopharmaceutics, single-use bioprocess container exhibit a vast number of advantages for cold chain logistics: Handling is easy, costs – both for acquisition, storage and transport – are low, ...
